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ND:YAG Laser

Beijing Superlaser Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Beijing Superlaser Technology Co., Ltd.
China (CN)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K193464
Device name
ND:YAG Laser
Company
Beijing Superlaser Technology Co., Ltd.
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-12-16
Decision date
2020-04-13
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Pigment treatmentVascular treatmentSkin resurfacing
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The ND:YAG Laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos.

Intended Use

The ND:YAG Laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos.

Device Description

The ND YAG Q-switch Laser Therapy Machine is a laser system which delivers laser at a wavelength of 1064nm or 532nm. It is for prescription use only.

Summary parsed at:2026-06-01 05:47:19 UTC

Predicate devices

2

K193464 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K193464 as a predicate