Manufacturer
Nanjing Bestview Laser S&T Co., Ltd.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
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
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
Predicate devices
1ND:YAG Laser
K260153 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K260153 as a predicate
