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Seodong Medical's NURIEYE-5800 has been proven for its safety and efficacy through clinical trials.
The eyes are the most precious organs in the human body and are particularly vulnerable to various risks due to their protruding nature. Therefore, it is essential to use products that have been validated for safety and efficacy. The eyelids are the softest skin on the human body, and the eyes should not be subjected to strong pressure or impact. Moreover, the eyes are protected by a mucous membrane (tear film), and exposing them to unverified hot temperatures can cause significant damage. Hence, it is imperative to use products that have been validated for safety and efficacy.
Among medical vibratory devices approved for the treatment of dry eye syndrome, there are currently no products, other than SERDONG MEDICAL’s NURIEYE-5800, that have undergone clinical trials conducted by institutions designated according to the Food and Drug Safety Ministry’s regulations and subsequently received approval through clinical data evaluation.
March 11, 2019 (Response Number: 2AA-1903-028300)
▼ Safety and efficacy clinical trial data for the treatment of dry eye syndrome. ▼
Our eyes blink approximately every 3 seconds and are exposed to various environmental pollutants due to excessive usage, ranging from 16 to 18 hours a day. Particularly, stress from activities like using electronic devices can lead to accumulated fatigue in the nerves, blood vessels, and cellular tissues surrounding the eyes. This can cause the muscles to tense up and become rigid, hindering the circulation of tears and blood, resulting in dry eye syndrome and deteriorating vision.
As we age, the tear ducts may become blocked, impeding the smooth flow of tears. Upon waking up, the eyes may feel stiff, and in severe cases, the area under the eyes may sag, leading to suffering from dry eye syndrome.
Starting from now, massaging around the eyes with the NURIEYE eye massager in the morning and evening can alleviate dry eye syndrome by relieving the nerves and blood vessels within the skin muscles and promoting the smooth circulation of tears. The NURIEYE-5800 product uses vibration massage, air pressure massage, and heat therapy to gently relax the muscles around the eyes, allowing for better nerve, blood vessel, and tear circulation. Additionally, the gentle warmth helps dissolve dust and foreign particles on the eye’s surface, as well as liquefy hardened fat secretions in the meibomian glands inside the eyelids, assisting in tear circulation and cleansing the eyes with fresh tears, thereby treating dry eye syndrome.
The mucin layer on the eye’s surface is one of the components that form the protective tear film. This mucin, mixed with water and oil components, creates a protective layer over the eye’s surface.
– Source: https://www.msdmanuals.com/ko-kr(MSD Manual) 中 “Eye Protection Function”
Originally, the eyelids should blink every 3 to 5 seconds, but modern individuals, due to the prevalence of electronic devices such as smartphones and widespread driving, may blink their eyes only every 7 to 10 seconds, which can lead to stiffening of the muscles around the eyes. When the muscles around the eyes stiffen, the communication between nerves, blood vessels, and tears becomes less efficient, resulting in poor circulation of tears. If left untreated, the fatty oils in the meibomian glands below the eyelids can harden, causing discomfort and stiffness in the eyes. Moreover, when the tear ducts, which should flush away dust and foreign particles, become blocked due to the accumulation of debris and tears, the excess tears may overflow from the eyes, especially when exposed to wind or bright sunlight.
Furthermore, if oil builds up under the eyes, causing blurriness in vision, it may indicate a problem with eye care. Blurred vision and eye discomfort can result from oil getting into the ducts where tears drain. Additionally, severe dry eye syndrome can lead to conjunctivitis, cataracts, eye fatigue, and headaches, and if left untreated, vision may deteriorate.
The entire NURIEYE-5800 series products are medical devices for treating dry eye syndrome. It has been announced through clinical papers that there has been a decrease in intraocular pressure.
NURIEYE-5800 completed clinical trials for safety and efficacy at two university hospitals’ clinical trial centers in accordance with the guidelines of the Ministry of Food and Drug Safety, and as a result, it has been approved by the Ministry of Food and Drug Safety as a “medical device for treating dry eye syndrome.”
The eyes are the most precious organs in the human body and are particularly vulnerable to various risks due to their protruding nature. Therefore, it is essential to use products that have been validated for safety and efficacy. The eyelids are the softest skin on the human body, and the eyes should not be subjected to strong pressure or impact. Moreover, the eyes are protected by a mucous membrane (tear film), and exposing them to unverified hot temperatures can cause significant damage. Hence, it is imperative to use products that have been validated for safety and efficacy.
Among medical vibratory devices approved for the treatment of dry eye syndrome, there are currently no products, other than SERDONG MEDICAL’s NURIEYE-5800, that have undergone clinical trials conducted by institutions designated according to the Food and Drug Safety Ministry’s regulations and subsequently received approval through clinical data evaluation.
March 11, 2019 (Response Number: 2AA-1903-028300)
Our eyes blink approximately every 3 seconds and are exposed to various environmental pollutants due to excessive usage, ranging from 16 to 18 hours a day. Particularly, stress from activities like using electronic devices can lead to accumulated fatigue in the nerves, blood vessels, and cellular tissues surrounding the eyes. This can cause the muscles to tense up and become rigid, hindering the circulation of tears and blood, resulting in dry eye syndrome and deteriorating vision.
As we age, the tear ducts may become blocked, impeding the smooth flow of tears. Upon waking up, the eyes may feel stiff, and in severe cases, the area under the eyes may sag, leading to suffering from dry eye syndrome.
Starting from now, massaging around the eyes with the NURIEYE eye massager in the morning and evening can alleviate dry eye syndrome by relieving the nerves and blood vessels within the skin muscles and promoting the smooth circulation of tears. The NURIEYE-5800 product uses vibration massage, air pressure massage, and heat therapy to gently relax the muscles around the eyes, allowing for better nerve, blood vessel, and tear circulation. Additionally, the gentle warmth helps dissolve dust and foreign particles on the eye’s surface, as well as liquefy hardened fat secretions in the meibomian glands inside the eyelids, assisting in tear circulation and cleansing the eyes with fresh tears, thereby treating dry eye syndrome.
The mucin layer on the eye’s surface is one of the components that form the protective tear film. This mucin, mixed with water and oil components, creates a protective layer over the eye’s surface.
– Source: https://www.msdmanuals.com/ko-kr(MSD Manual) 中 “Eye Protection Function”
Originally, the eyelids should blink every 3 to 5 seconds, but modern individuals, due to the prevalence of electronic devices such as smartphones and widespread driving, may blink their eyes only every 7 to 10 seconds, which can lead to stiffening of the muscles around the eyes. When the muscles around the eyes stiffen, the communication between nerves, blood vessels, and tears becomes less efficient, resulting in poor circulation of tears. If left untreated, the fatty oils in the meibomian glands below the eyelids can harden, causing discomfort and stiffness in the eyes. Moreover, when the tear ducts, which should flush away dust and foreign particles, become blocked due to the accumulation of debris and tears, the excess tears may overflow from the eyes, especially when exposed to wind or bright sunlight.
Furthermore, if oil builds up under the eyes, causing blurriness in vision, it may indicate a problem with eye care. Blurred vision and eye discomfort can result from oil getting into the ducts where tears drain. Additionally, severe dry eye syndrome can lead to conjunctivitis, cataracts, eye fatigue, and headaches, and if left untreated, vision may deteriorate.
The entire NURIEYE-5800 series products are medical devices for treating dry eye syndrome. It has been announced through clinical papers that there has been a decrease in intraocular pressure.
NURIEYE-5800 completed clinical trials for safety and efficacy at two university hospitals’ clinical trial centers in accordance with the guidelines of the Ministry of Food and Drug Safety, and as a result, it has been approved by the Ministry of Food and Drug Safety as a “medical device for treating dry eye syndrome.”
Seodong Medical's NURIEYE-5800" has been recognized by the Ministry of Health and Welfare as eligible for treatment purposes under the non-reimbursable medical care list!
Seodong Medical has received certification for its advanced medical technology “Thermal Massage Therapy for Dry Eye Treatment” for NURIEYE-5800, and has applied for and been accepted by the Ministry of Health and Welfare for health insurance coverage, with the health insurance non-reimbursable medical care list (Ministry of Health and Welfare Notice No. 2016-104) as follows:
Chapter 7 Non-Pharmaceutical Treatment Fees “Massage Therapy for Dry Eye Treatment” (MZ013)
* Standard Non-Reimbursable Treatment Cost: 7,820 won
Recognized as an advanced medical technology evaluation for NURIEYE-5800 by Seodong Medical, it has been included in the health insurance non-reimbursable medical care list, and since July 2016, treatment procedures have been performed at ophthalmology clinics and hospitals.
The results of the evaluation by the Health Insurance Review and Assessment Service confirmed the therapeutic purpose of NURIEYE-5800 from Seodong Medical, leading to its recognition.
Seodong Medical has received certification for its advanced medical technology “Thermal Massage Therapy for Dry Eye Treatment” for NURIEYE-5800, and has applied for and been accepted by the Ministry of Health and Welfare for health insurance coverage, with the health insurance non-reimbursable medical care list (Ministry of Health and Welfare Notice No. 2016-104) as follows:
Chapter 7 Non-Pharmaceutical Treatment Fees “Massage Therapy for Dry Eye Treatment” (MZ013)
* Standard Non-Reimbursable Treatment Cost: 7,820 won
Recognized as an advanced medical technology evaluation for NURIEYE-5800 by Seodong Medical, it has been included in the health insurance non-reimbursable medical care list, and since July 2016, treatment procedures have been performed at ophthalmology clinics and hospitals.
The results of the evaluation by the Health Insurance Review and Assessment Service confirmed the therapeutic purpose of NURIEYE-5800 from Seodong Medical, leading to its recognition.
Seodong Medical's NURIEYE-5800 has been certified as an advanced medical technology for "Thermal Massage Therapy for Dry Eye Treatment"!
NURIEYE-5800 has been clinically tested according to government regulations to prove its safety and efficacy in treating dry eye syndrome, and it has been approved as a “Medical Device for Dry Eye Treatment” by the Ministry of Food and Drug Safety.
Following this, Seodong Medical directly applied for evaluation of NURIEYE-5800’s dry eye treatment technology by the Korea Health Industry Development Institute on March 5, 2014.
(The thermal massage therapy for dry eye treatment is the technology certified for NURIEYE-5800!)
▼ Receipt of direct application for new medical technology to the Korea Health Industry Development Institute by Seodong Medical
According to the regulations on the operation of the New Medical Technology Evaluation Committee (Ministry of Health and Welfare Regulatory Rules Article 61, April 24, 2014), NURIEYE-5800 underwent safety and efficacy evaluation procedures for new medical technologies under [Regulation Article 3 of the Rules on New Medical Technology Evaluation], with the application number 2014-032, for “[Treatment of dry eye syndrome using eye massage].” Consequently, it was officially announced by the Ministry of Health and Welfare on November 3, 2014 (No. 2014-198).
(Technology Name – Thermal Massage Therapy for Dry Eye Syndrome Treatment)
The thermal massage therapy for the treatment of dry eye syndrome improves the function of the Meibomian glands and alleviates symptoms of dry eye syndrome, providing treatment to patients.
▼ The new medical technology application submitted by Seodong Medical was officially announced by the Ministry of Health and Welfare on November 3, 2014, as “Thermal Massage Therapy for Dry Eye Syndrome Treatment.” ▼
NURIEYE-5800 has been clinically tested according to government regulations to prove its safety and efficacy in treating dry eye syndrome, and it has been approved as a “Medical Device for Dry Eye Treatment” by the Ministry of Food and Drug Safety.
Following this, Seodong Medical directly applied for evaluation of NURIEYE-5800’s dry eye treatment technology by the Korea Health Industry Development Institute on March 5, 2014.
(The thermal massage therapy for dry eye treatment is the technology certified for NURIEYE-5800!)
According to the regulations on the operation of the New Medical Technology Evaluation Committee (Ministry of Health and Welfare Regulatory Rules Article 61, April 24, 2014), NURIEYE-5800 underwent safety and efficacy evaluation procedures for new medical technologies under [Regulation Article 3 of the Rules on New Medical Technology Evaluation], with the application number 2014-032, for “[Treatment of dry eye syndrome using eye massage].” Consequently, it was officially announced by the Ministry of Health and Welfare on November 3, 2014 (No. 2014-198).
(Technology Name – Thermal Massage Therapy for Dry Eye Syndrome Treatment)
The thermal massage therapy for the treatment of dry eye syndrome improves the function of the Meibomian glands and alleviates symptoms of dry eye syndrome, providing treatment to patients.
The research paper on the treatment of dry eye syndrome with NURIEYE-5800 has been published in the British Journal of Ophthalmology (BJO), a prestigious international academic journal in the field of ophthalmology.
The British Journal of Ophthalmology (BJO), a renowned international academic journal, invited a professor who conducted direct clinical trials to present a paper.
The presentation highlighted that NURIEYE-5800 has been proven to be effective and safe in treating dry eye syndrome. This announcement was made at an academic conference in November 2013, followed by the publication of the paper in the BJO in January 2014.
▼Y ou can review the translated version of the paper published in the British Journal of Ophthalmology (BJO) below. ▼
The British Journal of Ophthalmology (BJO), a renowned international academic journal, invited a professor who conducted direct clinical trials to present a paper.
The presentation highlighted that NURIEYE-5800 has been proven to be effective and safe in treating dry eye syndrome. This announcement was made at an academic conference in November 2013, followed by the publication of the paper in the BJO in January 2014.
"NURIEYE-5800" underwent clinical trials in accordance with the regulations of the Korea Food and Drug Administration (KFDA).
“NURIEYE-5800” applied for approval of the medical device clinical trial plan from the Korea Food and Drug Administration (KFDA) in accordance with the regulations announced on April 7, 2010, and conducted clinical trials at two university hospitals.
▼ Approval for clinical trials was received through Busan University Hospital and Inje University Busan Paik Hospital. ▼
▼ Clinical trials were conducted with a sample size of 144 patients diagnosed with dry eye syndrome, according to government statistics. ▼
The objective of the clinical trial was to demonstrate the superiority of the investigational medical device (NURIEYE-5800) over control group 1 (artificial tears) and the inferiority of the investigational medical device (NURIEYE-5800) compared to control group 2 (dry eye medication: Restasis).
The clinical trial was conducted with a total of 144 patients with dry eye syndrome. At Busan University Hospital, the trial took place from November 8, 2010, to May 6, 2011, while at Inje University Busan Paik Hospital, it occurred from November 12, 2010, to April 27, 2011. Each participant underwent a clinical trial for safety and efficacy using the NURIEYE device twice a day for 4 weeks, with each session lasting 15 minutes.
Some patients with dry eye syndrome experienced improvement in symptoms within a week, and after the 4-week clinical trial, their dry eye syndrome was treated effectively.
▼ NURIEYE underwent safety and efficacy clinical trials to verify its effectiveness in treating dry eye syndrome. ▼
▼ We are disclosing the safety and efficacy clinical trial review (results) for NURIEYE-5800.▼
“NURIEYE-5800” applied for approval of the medical device clinical trial plan from the Korea Food and Drug Administration (KFDA) in accordance with the regulations announced on April 7, 2010, and conducted clinical trials at two university hospitals.
The objective of the clinical trial was to demonstrate the superiority of the investigational medical device (NURIEYE-5800) over control group 1 (artificial tears) and the inferiority of the investigational medical device (NURIEYE-5800) compared to control group 2 (dry eye medication: Restasis).
The clinical trial was conducted with a total of 144 patients with dry eye syndrome. At Busan University Hospital, the trial took place from November 8, 2010, to May 6, 2011, while at Inje University Busan Paik Hospital, it occurred from November 12, 2010, to April 27, 2011. Each participant underwent a clinical trial for safety and efficacy using the NURIEYE device twice a day for 4 weeks, with each session lasting 15 minutes.
Some patients with dry eye syndrome experienced improvement in symptoms within a week, and after the 4-week clinical trial, their dry eye syndrome was treated effectively.
