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
1633–1656 of 2885
Cleared Aug 30, 2001
OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
K011769
Opusdent , Ltd.
General & Plastic Surgery · 84d
Cleared Aug 29, 2001
LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
K011703
Lumenis
General & Plastic Surgery · 89d
Cleared Aug 09, 2001
INTRALASE 600C LASER KERATOME
K002890
Intra Lase Corp.
General & Plastic Surgery · 328d
Cleared Aug 07, 2001
INPULSE DENTAL LASER
K011423
Incisive, LLC
General & Plastic Surgery · 90d
Cleared Aug 02, 2001
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
K011382
Photo Medex, Inc.
General & Plastic Surgery · 87d
Cleared Jul 24, 2001
LASER PERIPHERALS REUSABLE HOLMIUM FIBER
K011207
Laser Peripherals, LLC
General & Plastic Surgery · 96d
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 22, 2001
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER
K011677
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 23d
Cleared Jun 19, 2001
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
K010927
Medical Bio Care Sweden AB
General & Plastic Surgery · 83d
Cleared Jun 19, 2001
PROLITE VL PULSED LIGHT SYSTEM
K010928
Medical Bio Care Sweden AB
General & Plastic Surgery · 83d
Cleared Jun 14, 2001
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
K011409
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 37d
Cleared Jun 07, 2001
UNI-LASER 470
K010885
Medart Corp.
General & Plastic Surgery · 76d
Cleared May 22, 2001
PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
K003318
Paradigm Medical Industries, Inc.
General & Plastic Surgery · 210d
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 May 01, 2001
COOLTOUCH VARIA ND:YAG LASER SYSTEM
K010316
Cooltouch Corp.
General & Plastic Surgery · 88d
Cleared Apr 20, 2001
SOFTLASE - SURGICAL DIODE LASER SYSTEM
K003440
Zap Lasers, Inc.
General & Plastic Surgery · 165d
Cleared Apr 12, 2001
LASER MECHANISMS LASER SCANNING SYSTEM
K010113
Laser Mechanisms, Inc.
General & Plastic Surgery · 86d
Cleared Apr 11, 2001
CANDELA LONG PULSE ND:YAG
K010104
Candela Corp.
General & Plastic Surgery · 89d
Cleared Apr 05, 2001
NUVOLASE 532 MEDICAL LASER SYSTEM
K010046
American Laser Corp.
General & Plastic Surgery · 90d
Cleared Apr 02, 2001
CYNOSURE PHOTOGENICA DL
K010005
Cynosure, Inc.
General & Plastic Surgery · 90d