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510(k) Data Aggregation
(54 days)
The Nd: YAG Laser Therapy Systems is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology, as follows:
532nm wavelength:
- Removal of light ink (red, sky blue, green, purple, and orange) tattoo.
- Treatment of benign vascular lesions including, but not limited to: telangiectasias.
- Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi, freckles, Nevus spilus, Seborrheic Keratoses.
- Treatment of Post Inflammatory Hyper-Pigmentation.
1064nm wavelength:
- Removal dark ink (black, blue and brown) tattoo.
- Removal of benign dermal pigmented lesions including, but not limited to: Nevus of Ota, Common Nevi, and Melasma.
- Removal or lightening of unwanted hair with or without adjuvant preparation.
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.
The design and production of the Nd: YAG Laser Therapy Systems fully comply with the relevant national safety standards and quality standards for laser medical equipment testing requirements, and has reached the international advanced level. This machine adopts advanced optical technology and accessories. A multifunctional microcomputer can control and adjust the size of the laser spot,making it suitable for treating diseases in different parts of the body.
The Nd: YAG Laser Therapy Systems is a kind of laser pigment treatment instrument. It uses the principle of "photo-blasting". The laser emits high energy instantaneously, causing the pigment particles to absorb the laser energy and rapidly expand and rupture. Part of the pigment is broken down into smaller particles and excreted from the body, and the other part is swallowed by human macrophages and excreted through the lymphatic system.
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