Light Therapy Devices in Ophthalmology and Dermatology
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Nov 29, 2023- Analysis ID
- 230002670/PCBB-HCM
- Submission ID
- 000.00.19.H29-231004-0028
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- -EYE-LIGHT System is designed to treat certain clinical conditions in the field of ophthalmology, particularly those of a recurrent nature or related to dermatology. -Specifically, the EYE-LIGHT System utilizes the IPL - OPE® (multi-spectrum light therapy) and LLLT - LED LIGHT MODULATION® (monochromatic biostimulating light - LED) technologies and is indicated for the following treatments: IPL (OPE®) 600 – 1200nm It stimulates the secretion of lipids in the tear film of the patient, using the selective photothermal principle. The target cells in the affected area of the basal layer absorb the light energy, which is then converted into heat energy, causing localized warming. It is suitable for treating disorders of the meibomian glands (MGD), acne (pimples), and Sjogren's syndrome, when combined with red LLLT therapy. LLLT - Red LED 625 nm It activates the endogenous heating process of the skin, and particularly of the eyelids, through the emission of LED light. The energy of the red light stimulates reactions at the cellular level, increasing ATP (adenosine triphosphate) production and the activity of fibroblasts, thereby activating anti-inflammatory effects and stimulating the cellular mechanisms responsible for tissue repair and regeneration. It is indicated for treating disorders of the meibomian glands (MGD) and for treating chalazion (blocked meibomian gland), when combined with red LLLT therapy; It is indicated for treating chalazion (blocked meibomian gland) when used alone; It is indicated for treating blepharitis, acne (pimples), and Demodex-related dermatitis, when combined with green LLLT therapy; It is indicated for treating post-surgical eyelid conditions (ptosis, ectropion) and AMD (Age-related Macular Degeneration), when combined with yellow LLLT therapy.
- Registration Date
- Nov 29, 2023
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