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
2617–2640 of 2885
Cleared Dec 19, 1988
CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL.
K883488
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 125d
Cleared Dec 19, 1988
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE
K884459
Luxar Corp.
General & Plastic Surgery · 56d
Cleared Dec 15, 1988
SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP
K884994
Sharplan Lasers, Inc.
General & Plastic Surgery · 14d
Cleared Nov 25, 1988
KTP/532 SURGICAL LASER
K884029
Laserscope
General & Plastic Surgery · 63d
Cleared Nov 15, 1988
CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.
K883738
Directed Energy, Inc.
General & Plastic Surgery · 75d
Cleared Oct 27, 1988
MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS
K884311
Surgilase, Inc.
General & Plastic Surgery · 14d
Cleared Oct 27, 1988
MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS
K884313
Surgilase, Inc.
General & Plastic Surgery · 14d
Cleared Oct 13, 1988
SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL80
K884092
Surgilase, Inc.
General & Plastic Surgery · 15d
Cleared Sep 28, 1988
4000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C02
K883089
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 69d
Cleared Sep 27, 1988
SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS
K883563
Sharplan Lasers, Inc.
General & Plastic Surgery · 39d
Cleared Sep 09, 1988
KTP/YAG(TM) SURGICAL LASER
K882734
Laserscope
General & Plastic Surgery · 70d
Cleared Sep 09, 1988
MODEL AU-1 ACCESSORY UNIT
K882926
Directed Energy, Inc.
General & Plastic Surgery · 58d
Cleared Sep 02, 1988
HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900
K882365
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 86d
Cleared Aug 26, 1988
LQ1106 OPHTHALMIC YAG LASER
K882772
Keeler Instruments, Inc.
General & Plastic Surgery · 51d
Cleared Aug 17, 1988
SLT CONTACT LASER SYSTEM
K882212
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 83d
Cleared Jul 20, 1988
MODEL 20 KY KRYPTON YELLOW LASER
K881940
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 72d
Cleared Jul 08, 1988
4000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER
K881619
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 86d
Cleared Jul 05, 1988
SPTL-1 PULSED DYE LASER
K882243
Candela Laser Corp.
General & Plastic Surgery · 35d
Cleared Jun 27, 1988
KTP/532(TM) SURGICAL LASER
K881788
Laserscope
General & Plastic Surgery · 62d
Cleared Jun 20, 1988
FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM
K880061
Abbott Laboratories
General & Plastic Surgery · 165d
Cleared Jun 20, 1988
SHARPLAN MEDILAS 4060 N
K882037
Sharplan Lasers, Inc.
General & Plastic Surgery · 35d
Cleared Jun 03, 1988
MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY
K881580
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE
K881581
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE
K881582
Laser Engineering, Inc.
General & Plastic Surgery · 53d