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

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Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

3

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

1

K193477 references 1 predicate/reference device

Cited as predicate

3

3 submissions cite K193477 as a predicate