System of Light Therapy in Ophthalmology and Dermatology - Vietnam Registration 240002354/PCBB-HCM
Access comprehensive regulatory information for System of Light Therapy in Ophthalmology and Dermatology in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002354/PCBB-HCM and manufactured by ESPANSIONE MARKETING S.p.A. The authorized representative in Vietnam is CÔNG TY TNHH ANDAMAN MEDICAL VIỆT NAM.
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Device Details
Registration Details
240002354/PCBB-HCM
000.00.19.H29-240925-0008
Theo theo phụ lục
Theo phụ lục
Technical Details
The MEIBOMASK System is designed to treat certain clinical conditions in ophthalmology or dermatology, particularly those with a recurrence pattern. Specifically, the MEIBOMASK System utilizes LLLT - LED LIGHT MODULATION® (biological photostimulation - LED) technology and is indicated for the following treatments: LLLT - Red LED 625 nm It induces the endogenous warming of the skin and, in particular, the eyelids, through the emission of red LED light. The energy of the red light stimulates cellular responses at the mitochondrial level, increasing ATP (adenosine triphosphate) production and the activity of fibroblasts, thereby exerting anti-inflammatory effects and stimulating the cellular mechanisms responsible for tissue repair and regeneration. - Disorders of the meibomian glands (dry eye syndrome); - The Red LLLT is indicated for the treatment of dry eye; - When combined with Green LLLT, it is indicated for the treatment of blepharitis, acne rosacea (acne), and dermatitis caused by Demodex; - When combined with Yellow LLLT, it is indicated to facilitate the healing process after surgical correction of the eyelids. LLLT - Yellow LED 590 nm It affects the lymphatic system, stimulating cellular metabolism and having detoxifying and analgesic effects in cases of skin edema. - It stimulates cellular metabolism, which enhances the detoxification process and alleviates skin edema. When combined with red light, it stimulates the ATP production mechanism. It is suitable for treating (potentially in combination with Red LED) inflammatory conditions that arise from eyelid surgery. LLLT - Blue LED 465 nm Blue light is primarily absorbed by the epidermal layer of the skin. By stimulating the production of intracellular oxygen through the activation of porphyrins, it exerts an antibacterial effect. Combined with red light, it contributes to reducing the number of Demodex bacteria, which cause blepharitis or other localized conditions.
Dates and Status
Oct 16, 2024