System of Light Therapy in Ophthalmology and Dermatology - Vietnam Registration 240002356/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 240002356/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
240002356/PCBB-HCM
000.00.19.H29-240925-0005
Theo theo phụ lục
Theo phụ lục
Technical Details
The EYE-LIGHT System is designed to treat certain recurrent clinical conditions in ophthalmology and dermatology. Specifically, the EYE-LIGHT System utilizes the IPL - OPE® (Selective Photothermal Activation) and LLLT - LED LIGHT MODULATION® (Hormesis Photobiomodulation - 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 epidermis 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 the LED light. The energy of the red light stimulates the cellular reactions at the level of the mitochondria, increasing the production of ATP (adenosine triphosphate) and the activity of the fibroblasts, thus activating the anti-inflammatory effect and stimulating the cellular mechanisms responsible for tissue repair and regeneration. LLLT or combined IPL + Red LLLT therapy is indicated for treating disorders of the meibomian glands (MGD); Red LLLT alone is indicated for treating chalazion (blocked meibomian gland); Combined with Green LLLT, it is indicated for treating blepharitis, acne (pimples), and Demodex-induced dermatitis; Combined with Yellow LLLT, it is indicated for treating post-surgical ptosis (drooping eyelid) and AMD (Age-related Macular Degeneration). -LLLT – Yellow LED 590 nm (+/-40mm) 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 cellular exchange, which enhances the detoxification and alleviates the symptoms of skin swelling. Combined with red light, it stimulates the ATP production mechanism. It is suitable for treating (potentially combined with red LED light) the inflammatory conditions that arise from eyelid surgery, ptosis, and AMD. -LLLT - Green LED 465 nm (+/-40mm) Green light is mainly absorbed by the epidermis. By stimulating the formation of intracellular oxygen, it produces an antibacterial effect. Combined with red light, it contributes to reducing the number of Demodex mites, which cause blepharitis or other local conditions.
Dates and Status
Oct 16, 2024

