Q-Switched Nd: YAG Laser System (Glamor Q)

Nanjing Bestview Laser S&T 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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1

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Device details

FDA 510(k) registration fields

K number
K260153
Device name
Q-Switched Nd: YAG Laser System (Glamor Q)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2026-01-20
Decision date
2026-04-20
Submission type
Traditional
Technology type
Q-Switched(AI inferred)
Clinical applications
Pigment treatmentVascular treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The Q-Switched Nd:YAG Laser System is indicated for the treatment of: benign cutaneous lesions, such as warts, scars, striae, and psoriasis; benign pigmented lesions, including lentigines, nevi, and birthmarks; and the removal of black and/or blue tattoos.

Intended Use

The Q-Switched Nd:YAG Laser System is indicated for the treatment of: benign cutaneous lesions, such as warts, scars, striae, and psoriasis; benign pigmented lesions, including lentigines, nevi, and birthmarks; and the removal of black and/or blue tattoos.

Device Description

The laser system utilizes established nanosecond laser technology, with a pulse duration in the range of 5 to 8 ns. At this pulse duration, the concentrated laser energy (reaching up to 1000 mJ at 1064nm and 500 mJ at 532nm) is rapidly absorbed by the target chromophores, such as melanin in pigmented lesions. The primary mechanism of action is selective photothermolysis. The absorbed energy is converted into heat, causing instantaneous and localized thermal expansion, vaporization, and coagulation of the target structures. Because the pulse duration is shorter than the thermal relaxation time of the surrounding tissue, the thermal damage is confined primarily to the intended targets, minimizing collateral damage. For epidermal pigmentation, the disrupted target material forms fine debris, which is subsequently eliminated through natural epidermal exfoliation or crusting. For deeper dermal targets, such as tattoo ink particles, the laser energy fragments them into minute particles. These fragments are then recognized and engulfed by the body's macrophages. Finally, they are cleared from the body via the lymphatic circulation. As a result, the pigmented lesions gradually fade and are cleared over time following the treatment.

Summary parsed at:2026-06-01 05:19:10 UTC

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