Manufacturer
Sanhe Meditech Co., Ltd.Nd: YAG Laser Therapy Systems
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K260375
- Device name
- Nd: YAG Laser Therapy Systems
- Company
- Sanhe Meditech Co., Ltd.
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2026-02-05
- Decision date
- 2026-03-31
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatmentSurgical cutting
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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.
Summary parsed at:2026-06-01 05:19:25 UTC
Predicate devices
3Nd: YAG Laser Therapy Systems
Medical Diode Laser Hair Removal System
Nd: YAG Laser Therapy Systems HM-YL900
K260375 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K260375 as a predicate
