GEX · Class II · 21 CFR 878.4810

FDA Product Code GEX: Powered Laser Surgical Instrument

Under FDA product code GEX, powered laser surgical instruments are cleared for use across a broad range of surgical applications.

These devices use focused light energy to cut, ablate, vaporize, or coagulate tissue with high precision and minimal thermal damage to surrounding structures. They are used in ophthalmology, dermatology, urology, and general surgery.

GEX devices are Class II medical devices, regulated under 21 CFR 878.4810 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Cynosure, Inc., Sharplan Lasers, Inc. and Quanta System Spa.

2885
Total
2885
Cleared
126d
Avg days
1978
Since
2885 devices
1657–1680 of 2885
Cleared Mar 29, 2001
CYNOSURE PHOTOGENICA NEO-V
K004039
Cynosure, Inc.
General & Plastic Surgery · 90d
Cleared Mar 27, 2001
F1 DIODE LASER SYSTEM
K004021
Opus Medical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 26, 2001
DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)
K003993
Dornier Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Mar 26, 2001
SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
K004006
Lumenis, Inc.
General & Plastic Surgery · 90d
Cleared Mar 16, 2001
INDIGO LASEROPTIC TREATMENT SYSTEM
K003952
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 85d
Cleared Mar 16, 2001
INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001
K003953
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 85d
Cleared Mar 16, 2001
MD 30 COMPACT
K004014
General Project
General & Plastic Surgery · 84d
Cleared Mar 15, 2001
LASEREX INTEGRE, MODEL LP2532
K003955
Ellex Medical Pty, Ltd.
General & Plastic Surgery · 84d
Cleared Mar 13, 2001
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
K003614
Coherent Star
General & Plastic Surgery · 111d
Cleared Mar 07, 2001
SLT DIFFUSER FIBER
K010041
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 61d
Cleared Mar 06, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
K003765
Laserscope
General & Plastic Surgery · 90d
Cleared Mar 01, 2001
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
K003705
Photo Medex, Inc.
General & Plastic Surgery · 90d
Cleared Mar 01, 2001
COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II
K003715
Cooltouch Corp.
General & Plastic Surgery · 90d
Cleared Mar 01, 2001
PALOMAR SPALIGHT PULSED LIGHT SYSTEM
K003886
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 73d
Cleared Mar 01, 2001
CONTOUR PROFILE LASER
K010285
Sciton, Inc
General & Plastic Surgery · 29d
Cleared Feb 22, 2001
VISULAS YAG II
K003885
Carl Zeiss, Inc.
General & Plastic Surgery · 69d
Cleared Jan 25, 2001
TWILITE, TWILITE WHITE
K003385
Biolase Technology, Inc.
General & Plastic Surgery · 86d
Cleared Jan 25, 2001
PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM
K003460
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 79d
Cleared Jan 25, 2001
DENLASER, MODEL 800
K003541
CAO Group, Inc.
General & Plastic Surgery · 70d
Cleared Jan 10, 2001
FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II
K003202
Altus Medical
General & Plastic Surgery · 90d
Cleared Jan 08, 2001
MICROPOBE SERIES OF LASERS AND ACCESSORIES
K003151
Endooptiks, Inc.
General & Plastic Surgery · 90d
Cleared Dec 20, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210
K002308
Trimedyne, Inc.
General & Plastic Surgery · 145d
Cleared Dec 20, 2000
COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
K003781
Cooltouch Corp.
General & Plastic Surgery · 13d
Cleared Dec 15, 2000
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
K003147
Laserscope
General & Plastic Surgery · 66d