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
841–864 of 2885
Cleared Jan 13, 2012
EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
K112013
Biolitec, Inc.
General & Plastic Surgery · 183d
Cleared Dec 22, 2011
VARI-LASE WIREFIBER LASER FIBER
K113140
Vascular Solutions, Inc.
General & Plastic Surgery · 58d
Cleared Dec 21, 2011
DERMATOLOGICAL TREATMENT DEVICE FAMILY
K111303
Sharplight Technologies, Ltd.
General & Plastic Surgery · 226d
Cleared Dec 16, 2011
TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM
K112987
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 71d
Cleared Dec 07, 2011
DORNIER MEDILAS D LITEBEAM+ 1470
K110364
Dornier Medtech America, Inc.
General & Plastic Surgery · 303d
Cleared Nov 16, 2011
DENTAL LASER THERAPY SYSTEM
K113212
China Daheng Group, Inc.
General & Plastic Surgery · 15d
Cleared Nov 03, 2011
ENDOVASCULAR LASER VEIN SYSTEM KIT
K112299
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 85d
Cleared Oct 21, 2011
ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
K112166
W and R Investments Dba Laser Engineering
General & Plastic Surgery · 85d
Cleared Oct 05, 2011
CANDELA GENTLEMAX FAMILY OF LASERS
K112715
Candela Corp.
General & Plastic Surgery · 16d
Cleared Sep 30, 2011
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
K112442
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 37d
Cleared Sep 28, 2011
AURIGA XL
K111475
Starmedtec GmbH
General & Plastic Surgery · 124d
Cleared Sep 20, 2011
CERALAS 147NM DIODE LASER SYSTEM
K112253
Biolitec, Inc.
General & Plastic Surgery · 46d
Cleared Sep 16, 2011
PICASSO/ PICASSO LITE/ PICASSO PERIO
K102359
Amd Lasers, LLC
General & Plastic Surgery · 393d
Cleared Sep 14, 2011
SHEAUMANN PL-980
K111360
Sheaumann Lasers
General & Plastic Surgery · 121d
Cleared Sep 13, 2011
SHEAUMANN PL-1064
K111359
Sheaumann Lasers
General & Plastic Surgery · 120d
Cleared Sep 13, 2011
ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
K112031
Alma Lasers, Inc.
General & Plastic Surgery · 60d
Cleared Sep 06, 2011
CERALAS 980NM DIODE LASER FAMILY
K112324
Biolitec Medical Devices, Inc.
General & Plastic Surgery · 25d
Cleared Aug 25, 2011
YOULASER CO2 LASER SYSTEM
K111592
Quanta System Spa
General & Plastic Surgery · 79d
Cleared Jul 25, 2011
VISION ONE LASER SYSTEM
K111213
Lumenis, Inc.
General & Plastic Surgery · 84d
Cleared Jul 18, 2011
CANDELA GENTLELASE FAMILY OF LASERS
K111144
Candela Corp.
General & Plastic Surgery · 87d
Cleared Jul 08, 2011
MEDIOSTAR NEXT
K111851
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 9d
Cleared Jul 01, 2011
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
K101306
Fotona D.D.
General & Plastic Surgery · 417d
Cleared Jul 01, 2011
CORTEX CO2 / ER:YAG LASER SYSTEM
K110897
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 93d
Cleared Jun 28, 2011
MEDART DIODE LASER SYSTEM & ACCESSORIES
K110243
Medart A/S
General & Plastic Surgery · 152d