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
1033–1056 of 2885
Cleared Sep 11, 2008
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
K081704
Lumenis, Inc.
Ophthalmic · 86d
Cleared Sep 09, 2008
PASCAL SYNTHESIS DELIVERY SYSTEM
K081744
Optimedica Corporation
General & Plastic Surgery · 82d
Cleared Sep 03, 2008
STARLIGHT, MODEL PD9012
K073317
F.P. Rubinstein Y Cia S.R.L.
General & Plastic Surgery · 282d
Cleared Aug 28, 2008
CLAROS NANO DENTAL LASER SYSTEM
K081652
Elexxion AG
General & Plastic Surgery · 77d
Cleared Aug 27, 2008
SCULPTURE 2.94 ER:YAG SYSTEM
K073158
Hoya Conbio, Inc.
General & Plastic Surgery · 293d
Cleared Aug 20, 2008
MEDILAS D FAMILY LASERS
K073427
Dornier Medtech America, Inc.
General & Plastic Surgery · 258d
Cleared Aug 15, 2008
MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
K080530
Cutera, Inc.
General & Plastic Surgery · 171d
Cleared Aug 12, 2008
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY
K081939
Omniguide, Inc.
General & Plastic Surgery · 35d
Cleared Aug 08, 2008
ATRILAZE LASER ABLATION SYSTEM
K081457
Medical Cv, Inc.
General & Plastic Surgery · 77d
Cleared Aug 08, 2008
LASERPEEL SOFT-MET MODIFIED ERBIUM LASER
K082028
Global USA Distribution, LLC
General & Plastic Surgery · 22d
Cleared Aug 07, 2008
FAMILI OF IRIDEX IQ LASER SYSTEMS
K071687
Iridex Corp
General & Plastic Surgery · 416d
Cleared Jul 31, 2008
NANNOLIGHT INTENSE PULSED LIGHT SYSTEM
K082033
Global USA Distribution, LLC
General & Plastic Surgery · 14d
Cleared Jul 23, 2008
ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES
K080463
Alma Lasers , Ltd.
General & Plastic Surgery · 154d
Cleared Jul 18, 2008
CHROMOLITE EP
K081619
Chromogenex Technologies Limited
General & Plastic Surgery · 39d
Cleared Jul 17, 2008
PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
K080731
Osyris
General & Plastic Surgery · 125d
Cleared Jul 15, 2008
FENCER 308 EXCIMER LASER SYSTEM
K080975
Kera Harvest/Laser Max Medical Technologies Corp
General & Plastic Surgery · 99d
Cleared Jul 10, 2008
KEY LASER III 1243 US WITH DETECT
K073074
Kavo America
General & Plastic Surgery · 253d
Cleared Jul 08, 2008
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
K081015
Biolitec, Inc.
General & Plastic Surgery · 90d
Cleared Jul 07, 2008
MOSAIC ECO2 LASER SYSTEM
K080496
Lutronic Corporation
General & Plastic Surgery · 136d
Cleared Jul 01, 2008
FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES
K080915
Reliant Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jun 30, 2008
APOLLO MINI IPL SYSTEM
K081219
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 61d
Cleared Jun 27, 2008
ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060
K072182
Alma Lasers , Ltd.
General & Plastic Surgery · 326d
Cleared Jun 27, 2008
DORNIER MEDILAS D 30 LASER, MEDILAS D 1064
K080959
Dornier Medtech America, Inc.
General & Plastic Surgery · 85d
Cleared Jun 25, 2008
AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS
K081612
Aesculight, LLC
General & Plastic Surgery · 16d