Nanjing Bestview Laser S&T Co., Ltd. · Class II · Cleared Apr 20, 2026
| K-number | K260153 |
| Device name | Q-Switched Nd: YAG Laser System (Glamor Q) |
| Applicant | Nanjing Bestview Laser S&T Co., Ltd. |
| Product code | GEX |
| Device class | Class II |
| Decision date | Apr 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The Q-Switched Nd:YAG Laser System (Glamor Q) is a nanosecond laser device indicated for treating benign cutaneous lesions (warts, scars, striae, psoriasis), benign pigmented lesions (lentigines, nevi, birthmarks), and removing black and/or blue tattoos. It works by selective photothermolysis, where concentrated laser energy is rapidly absorbed by target chromophores like melanin, causing thermal fragmentation and clearance of pigmented lesions over time.
The proposed device has identical wavelength, maximum output energy (1000 mJ at 1064nm and 500 mJ at 532nm), and pulse width (5–8 nanoseconds) as the predicate device. Only minor differences in machine size and weight exist, which are unimportant and do not negatively affect safety or effectiveness.
EMC/electrical safety per ANSI AAMI ES60601-1:2005 and IEC 60601-1-2:2014; laser safety per IEC 60825 Edition 3.0; biocompatibility (cytotoxicity, irritation, sensitization) per ISO 10993-5, ISO 10993-10, and ISO 10993-23; software per IEC 62304; and surgical laser equipment performance per IEC 60601-2-22 Edition 4.0.
View the full FDA submission: accessdata.fda.gov