Light Therapy Devices in Ophthalmology and Dermatology - Vietnam Registration 230002668/PCBB-HCM
Access comprehensive regulatory information for Light Therapy Devices in Ophthalmology and Dermatology in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 230002668/PCBB-HCM and manufactured by Espansione Marketing S.p.A..
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Device Details
Registration Details
230002668/PCBB-HCM
000.00.19.H29-231004-0030
MY MASK-E
MY MASK-E/PSN
Technical Details
MY MASK-E Medical Device 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 eye specialists (ophthalmologists/eye technicians) or at home by non-professional users, for the following purposes: LLLT - Red LED 625 nm It stimulates the natural healing process of the skin, particularly the eyelids, by the emission of the red LED. The energy of the red light stimulates the reactions at the cellular level, increasing the production of ATP (adenosine triphosphate) and the activity of the fibroblasts, and activates the anti-inflammatory effect and stimulates the cellular mechanisms responsible for tissue repair and regeneration. - Red LLLT is indicated for the treatment of meibomian gland dysfunction (dry eye) and for eye patching; - When combined with Green LLLT, it is indicated for the treatment of blepharitis, acne (pimples) and dermatitis caused by Demodex; - When combined with Yellow LLLT, it is indicated to facilitate the healing process after corrective eyelid surgery. LLLT – Yellow LED 590 nm It affects the lymphatic system, stimulates the cell metabolism, and has a detoxifying and pain-relieving effect in cases of skin swelling. - It stimulates the cell metabolism, which enhances the detoxification process and alleviates skin swelling. When combined with the red light, it stimulates the ATP production mechanism. It is suitable for the treatment (potentially combined with the red LED) of 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, it creates an antibacterial effect. - When combined with Red LLLT, it is indicated for the treatment of blepharitis, acne (pimples) and dermatitis caused by Demodex
Dates and Status
Nov 29, 2023

