GEXClass II

Powered Laser Surgical Instrument

21 CFR 878.4810 / General, Plastic Surgery

GEX is the FDA product code for Powered Laser Surgical Instrument, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic...". As of 2026-09-10, FDA records hold 2,876 510(k) clearances under this code, the most recent dated 2026-08-27, and 201 recalls.

Classification record

Product code: GEX
Device name: Powered Laser Surgical Instrument
FDA definition: A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
Regulation: 21 CFR 878.4810
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 2,887
Ingested recalls: 201

Clearances, product code GEX

By decision year

2,887 clearances under product code GEX with a decision year between 1978 and 2026, 1994 the highest year at 118.

Show the numbers

510(k) clearances under FDA product code GEX by decision year
Year	Clearances
1978	2
1979	2
1980	2
1982	2
1984	8
1985	25
1986	42
1987	23
1988	66
1989	72
1990	110
1991	92
1992	88
1993	77
1994	118
1995	98
1996	63
1997	93
1998	81
1999	76
2000	68
2001	74
2002	94
2003	98
2004	78
2005	69
2006	83
2007	73
2008	107
2009	69
2010	50
2011	41
2012	45
2013	46
2014	61
2015	47
2016	51
2017	67
2018	51
2019	41
2020	52
2021	53
2022	60
2023	52
2024	82
2025	83
2026	52

Applicants with the most clearances

Product code GEX

Applicants holding the most 510(k) clearances under product code GEX
Applicant	Clearances
Cynosure, LLC	84
Candela Corporation	74
Sharplan Lasers, Inc.	66
Lumenis Ltd	64
Quanta System Inc.	57
Laserscope	49
Trimedyne, Inc.	48
Heraeus Lasersonics, Inc.	37
Surgical Laser Technologies, Inc.	35
Pfizer Laser Systems	30

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 448 companies shown, in name order