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Nd: YAG Laser Therapy System (QN-1)

Hebei JT Medical Co., Ltd.

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

Product code GEX· 21 CFR 878.4810

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Company

Hebei JT Medical Co., Ltd.
China (CN)

Product code

GEX
21 CFR 878.4810

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1
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Device details

FDA 510(k) registration fields

K number
K250722
Device name
Nd: YAG Laser Therapy System (QN-1)
Company
Hebei JT Medical Co., Ltd.
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-03-10
Decision date
2025-06-06
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Pigment treatmentVascular treatmentAcne treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The Nd: YAG Laser Therapy System 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 Therapy System 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 Laser Therapy System (Model: QN-1) is a laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse. In the laser handpiece, there is one optical cavity containing the Nd:YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect.

Summary parsed at:2026-06-01 05:22:32 UTC

Predicate devices

1

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