System of Light Therapy in Ophthalmology and Dermatology - Vietnam Registration 240002355/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 240002355/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
240002355/PCBB-HCM
000.00.19.H29-240925-0007
Theo theo phụ lục
Theo phụ lục
Technical Details
The MY MASK-E System is equipped with the LIGHT MODULATION® (biological light stimulation - LED) technology and is used to treat eye-related conditions and skin diseases in this field, as prescribed by specialists in this field (ophthalmologists/eye specialists/ophthalmic technicians) or at home by non-professional users, for the following purposes: LLLT - Red LED 625 nm It stimulates the process of endogenous skin warming and, in particular, the eyelid area, through the emission of red LED light. The energy of the red light stimulates the reactions at the cellular level, increasing the production of ATP (adenosine triphosphate) and the activity of fibroblasts, thus activating the anti-inflammatory effect and stimulating the cellular mechanisms responsible for tissue repair and regeneration. -LLLT RED is indicated for the treatment of meibomian gland dysfunction (dry eye syndrome) and for eye patching; -when combined with LLLT GREEN, it is indicated for the treatment of blepharitis, acne vulgaris (common acne) and dermatitis caused by Demodex; -when combined with LLLT GOLD, it is indicated to facilitate the healing process after surgical correction of the eyelid. LLLT – Gold LED 590 nm It affects the lymphatic system, stimulating the exchange of cells and having a detoxifying and analgesic effect in cases of skin swelling. -It stimulates the exchange of cells, thus enhancing the detoxification process and alleviating skin swelling. When combined with red light, it stimulates the ATP production mechanism. It is suitable for treating (possibly in combination with the Red LED) inflammatory conditions resulting from eyelid surgery. LLLT - Green LED 465 nm Green light is mainly absorbed by the epidermis layer of the skin. By stimulating the production of intracellular oxygen through the action of porphyrins, it produces an antibacterial effect. -When combined with LLLT RED, it is indicated for the treatment of blepharitis, acne vulgaris (common acne) and dermatitis caused by Demodex
Dates and Status
Oct 16, 2024