Nd:Yag Laser Therapy Systems

Beijing Unt 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

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2

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0

Device details

FDA 510(k) registration fields

K number
K232532
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
2023-08-21
Decision date
2023-11-02
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 Nd: Yag Laser Therapy Systems 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

Intended Use

The Nd: Yag Laser Therapy Systems 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

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. The Nd:Yag laser therapy systems is mainly composed of a host, an operating hand tool and a foot switch. The operation hand is a treatment hand. The host is composed of a power module, a control module and a display module.

Summary parsed at:2026-06-01 05:33:20 UTC

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