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.

2871
Total
2871
Cleared
126d
Avg days
1978
Since
2871 devices
1009–1032 of 2871
Cleared Sep 07, 2001
CYNOSURE ACCLAIM DERMATOLOGY LASER
K011828
Cynosure, Inc.
General & Plastic Surgery · 87d
Cleared Aug 30, 2001
PALOMAR LC 100 DIODE LASER
K011747
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 86d
Cleared Jul 09, 2001
CANDELA SPTL-1E PULSED DYE LASER
K011092
Candela Corp.
General & Plastic Surgery · 90d
Cleared Jul 03, 2001
WATERLASE, MILLENNIUM
K011041
Biolase Technology, Inc.
General & Plastic Surgery · 89d
Cleared Jun 14, 2001
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
K011409
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 37d
Cleared May 22, 2001
PALOMAR SLP 1000
K010580
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 84d
Cleared May 21, 2001
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
K010834
Laserscope
General & Plastic Surgery · 62d
Cleared May 18, 2001
MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM
K010689
Biolitec, Inc.
General & Plastic Surgery · 71d
Cleared May 01, 2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
K010284
Laserscope
General & Plastic Surgery · 90d
Cleared Apr 11, 2001
CANDELA LONG PULSE ND:YAG
K010104
Candela Corp.
General & Plastic Surgery · 89d
Cleared Apr 02, 2001
CYNOSURE PHOTOGENICA DL
K010005
Cynosure, Inc.
General & Plastic Surgery · 90d
Cleared Mar 29, 2001
CYNOSURE PHOTOGENICA NEO-V
K004039
Cynosure, 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 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
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 Dec 20, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210
K002308
Trimedyne, Inc.
General & Plastic Surgery · 145d