GEX · Powered Laser Surgical Instrument
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | GEX |
|---|---|
| Device Name | Powered Laser Surgical Instrument |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
Classification Rationale
(1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 2866)
Showing 20 most recent of 2866 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | Jun 4, 2026 | SESE |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | May 29, 2026 | SESE |
| K260138 | LUNE PureHygiene | Enamel Pure | May 29, 2026 | SESE |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | May 21, 2026 | SESE |
| K260100 | MOSES Raydar™ | Boston Scientific Corporation | May 18, 2026 | SESE |
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. | May 11, 2026 | SESE |
| K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | May 7, 2026 | SESE |
| K260256 | Q-Switched Nd: YAG Laser Systems | Shanghai Apolo Medical Technology Co., Ltd. | May 4, 2026 | SESE |
| K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) | Leaseir Technologies, Slu | May 4, 2026 | SESE |
| K261094 | YellowStar | Asclepion Laser Technologies GmbH | Apr 29, 2026 | SESE |
| K253765 | VANISH PRO | Ddc Technologies, Inc. | Apr 22, 2026 | SESE |
| K260153 | Q-Switched Nd: YAG Laser System (Glamor Q) | Nanjing Bestview Laser S&T Co., Ltd. | Apr 20, 2026 | SESE |
| K260307 | Diode Laser Therapy Systems (V19) | Weifang Mingliang Electronics Co., Ltd. | Apr 15, 2026 | SESE |
| K260017 | Picosecond Nd:YAG Laser Systems (Model: HS-298) | Shanghai Apolo Medical Technology Co., Ltd. | Apr 9, 2026 | SESE |
| K260375 | Nd: YAG Laser Therapy Systems | Sanhe Meditech Co., Ltd. | Mar 31, 2026 | SESE |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd. | Mar 28, 2026 | SESE |
| K260632 | LASER THERMAL THERAPY KIT | Elesta S.P.A | Mar 17, 2026 | SESE |
| K252971 | Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | C.R. Bard, Inc. | Mar 17, 2026 | SESE |
| K254197 | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | Mar 11, 2026 | SESE |
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Mar 6, 2026 | SESE |
Top Applicants
- Cynosure, Inc. — 80 clearances
- Sharplan Lasers, Inc. — 66 clearances
- Quanta System Spa — 57 clearances
- Laserscope — 49 clearances
- Trimedyne, Inc. — 48 clearances
