Manufacturer
Beijing Kes Biology Technology Co., Ltd.Nd: YAG Laser Therapy Systems
Beijing Kes Biology Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K193477
- Device name
- Nd: YAG Laser Therapy Systems
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2019-12-16
- Decision date
- 2020-06-24
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Surgical cuttingPigment treatmentVascular treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The device is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm wavelength: -Tattoo removal: light ink (red, tan, purple, orange, skyblue, green) -Removal of Epidermal Benign Pigmented Lesions -Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias -Treatment of Lentigines -Treatment of Cafe-Au-Lait -Treatment of Seborrheic Keratoses -Treatment of Post Inflammatory Hyper-Pigmentation -Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm Wavelength: -Tattoo removal: dark ink (black, blue and brown) -Removal of Nevus of Ota -Removal or lightening of unwanted hair with or without adjuvant preparation. -Treatment of Common Nevi -Skin resurfacing procedures for the treatment of acne scars and wrinkles
Intended Use
The device is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. 532nm wavelength: -Tattoo removal: light ink (red, tan, purple, orange, skyblue, green) -Removal of Epidermal Benign Pigmented Lesions -Removal of Minor Benign Vascular Lesions including but not limited to telangiectasias -Treatment of Lentigines -Treatment of Cafe-Au-Lait -Treatment of Seborrheic Keratoses -Treatment of Post Inflammatory Hyper-Pigmentation -Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm Wavelength: -Tattoo removal: dark ink (black, blue and brown) -Removal of Nevus of Ota -Removal or lightening of unwanted hair with or without adjuvant preparation. -Treatment of Common Nevi -Skin resurfacing procedures for the treatment of acne scars and wrinkle
Device Description
The proposed device is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. The device can produce 1064nm and 532nm two different laser wavelengths to treat the different color skin. It consists of power supply module, microprocessor control module, laser treatment handpiece module, operation display module and cooling system module. The physician is able to select the desired wavelength and the related output energy via control panel.
Summary parsed at:2026-06-01 05:47:22 UTC
Predicate devices
1CuRAS Nd:YAG Laser
K193477 references 1 predicate/reference device
Cited as predicate
3MEDIYAG
Nd:Yag Laser Therapy Systems
Nd: YAG Laser Therapy Systems
3 submissions cite K193477 as a predicate
