GEXFDA Class 2 · 21 CFR 878.4810
Powered Laser Surgical Instrument
Device family · General, Plastic Surgery
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
2,856
Manufacturers
180
Flagged signals
13
Adverse-event reports
39,370
Code matrix
| FDA product code | GEX |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| GMDN | — (crosswalk pending) |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2011 | 4 | 443.4 | 1,353 |
| Other | 2013 | 9 | 122.2 | 965 |
| Other | 2014 | 9 | 122.2 | 965 |
| Other | 2013 | 6 | 81.4 | 400 |
| Other | 2008 | 7 | 68.5 | 401 |
| Other | 2012 | 5 | 32.9 | 125 |
| Other | 2013 | 3 | 29.3 | 56 |
| Other | 2011 | 4 | 26.3 | 74 |
| Other | 2011 | 3 | 10.2 | 17 |
| Other | 2013 | 3 | 6.8 | 10 |
| Other | 2023 | 3 | 4.7 | 5 |
| Injury | 2020 | 4 | 2.6 | 4 |
| Injury | 2007 | 4 | 2.6 | 4 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 39,370 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Cynosure, Inc. | 80 | 2018 | — |
| Sharplan Lasers, Inc. | 66 | 1997 | — |
| QUANTA SYSTEM SPA | 57 | 2025 | — |
| Laserscope | 49 | 2006 | — |
| TRIMEDYNE, INC. | 48 | 2005 | — |
| Candela Corp. | 47 | 2019 | — |
| Surgical Laser Technologies, Inc. | 35 | 2004 | — |
| Lumenis, Inc. | 32 | 2022 | — |
| Biolitec, Inc. | 28 | 2012 | — |
| NEW STAR LASERS, INC. | 27 | 2014 | — |
| Asclepion Laser Technologies GmbH | 26 | 2025 | — |
| Directed Energy, Inc. | 24 | 1991 | — |
| DORNIER MEDTECH AMERICA, INC. | 24 | 2022 | — |
| Nidek, Inc. | 22 | 2004 | — |
| Candela Laser Corp. | 21 | 1996 | — |
| Lutronic Corporation | 20 | 2022 | — |
| CUTERA, INC. | 20 | 2025 | — |
| Cooper Lasersonics, Inc. | 18 | 1988 | — |
| Carl Zeiss, Inc. | 17 | 2001 | — |
| Angiodynamics, Inc. | 16 | 2023 | — |
| CAO GROUP, INC. | 16 | 2026 | — |
| Sunrise Technologies, Inc. | 15 | 1994 | — |
| Laser Engineering, Inc. | 15 | 2022 | — |
| OMNIGUIDE, INC. | 14 | 2021 | — |
| Vascular Solutions, Inc. | 13 | 2011 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
VANISH PRO · Ddc Technologies, Inc.510(k) · 2026-04-22
Q-Switched Nd: YAG Laser System (Glamor Q) · Nanjing Bestview Laser S&T Co., Ltd.510(k) · 2026-04-20
Diode Laser Therapy Systems (V19) · Weifang Mingliang Electronics Co., Ltd.510(k) · 2026-04-15
Picosecond Nd:YAG Laser Systems (Model: HS-298) · Shanghai Apolo Medical Technology Co., Ltd.510(k) · 2026-04-09
Nd: YAG Laser Therapy Systems · Sanhe Meditech Co., Ltd.510(k) · 2026-03-31
CO2 Laser System · Sanhe Meditech Co., Ltd.510(k) · 2026-03-28
LASER THERMAL THERAPY KIT · Elesta S.P.A510(k) · 2026-03-17
Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) · C.R. Bard, Inc.510(k) · 2026-03-17
Picasso Pro Diode Laser (002-00460) · CAO Group, Inc.510(k) · 2026-03-11
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.510(k) · 2026-03-06
CO2 Laser Treatment Machine (CFR3M1) · Haidari Beauty Technology (Beijing) Co., Ltd.510(k) · 2026-03-03
Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) · Beijing HuaCheng Taike Technology Co., Ltd.510(k) · 2026-02-27
Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) · Beijing HuaCheng Taike Technology Co., Ltd.510(k) · 2026-02-27
CAPRI · ORO Co., Ltd.510(k) · 2026-02-26
Diode Laser Therapy Systems (WLA-02) · Wingderm Electro-Optics , Ltd.510(k) · 2026-02-24
BTL-754FF · BTL Industries, Inc.510(k) · 2026-02-18
808nm semiconductor laser hair removal machine · Xi'An Taibo Electronic Technology Co., Ltd.510(k) · 2026-02-03
Boston PICO (Boston PICO) · Boston Aesthetics, Inc.510(k) · 2026-01-30
Holmium Laser Therapeutic Apparatus (HZ-40) · Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.510(k) · 2026-01-24
Vydence Family of Lasers · Vydence Medical Industria E Commercio Ltda510(k) · 2026-01-24
Boston Pico755 · Boston Aesthetics, Inc.510(k) · 2026-01-21
PICO-K · Speclipse, Inc.510(k) · 2025-12-24
JOULE 1064nm System and Accessories · Sciton, Inc510(k) · 2025-12-19
CO2 Laser Therapy System (Model: LFS-D9U) · Sanhe Lefis Electronics Co., Ltd.510(k) · 2025-12-19
SANDRO Dual · Wontech Co., Ltd.510(k) · 2025-12-19
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.