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
2641–2664 of 2885
Cleared Jun 03, 1988
MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT
K881583
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE
K881584
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE
K881585
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-45 CO2 LASER FOR ENT APPLICATIONS
K881586
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS
K881587
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
MODEL MD-25 LASER FOR SURGICAL USE
K881588
Laser Engineering, Inc.
General & Plastic Surgery · 53d
Cleared Jun 03, 1988
SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI.
K881952
Sharplan Lasers, Inc.
General & Plastic Surgery · 24d
Cleared Jun 03, 1988
SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU
K881953
Sharplan Lasers, Inc.
General & Plastic Surgery · 24d
Cleared Jun 02, 1988
MODIFIED SHARPLAN MODEL 1020 CO2 LASER
K882180
Sharplan Lasers, Inc.
General & Plastic Surgery · 30d
Cleared May 24, 1988
LASER MICROMANIPULATOR
K881824
Pfizer Laser Systems
General & Plastic Surgery · 25d
Cleared May 24, 1988
SHARPLAN ND:YAG SURGICAL HAND APPLICATORS
K881870
Sharplan Lasers, Inc.
General & Plastic Surgery · 21d
Cleared May 13, 1988
SHARPLAN 719Y MICROSLAD(TM)
K881887
Sharplan Lasers, Inc.
General & Plastic Surgery · 8d
Cleared May 11, 1988
MODIFIED MODEL 2100 ND:YAG LASER
K881848
Sharplan Lasers, Inc.
General & Plastic Surgery · 9d
Cleared May 03, 1988
MODEL PC ARGON LASER
K880908
Hgm, Inc.
General & Plastic Surgery · 61d
Cleared Apr 18, 1988
ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU
K880807
Cooper Lasersonics, Inc.
General & Plastic Surgery · 52d
Cleared Apr 18, 1988
ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU
K880808
Cooper Lasersonics, Inc.
General & Plastic Surgery · 52d
Cleared Apr 18, 1988
ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU
K880809
Cooper Lasersonics, Inc.
General & Plastic Surgery · 52d
Cleared Mar 11, 1988
COHERENT XA-40 CO2 SURGICAL LASER
K880603
Coherent Medical Group
General & Plastic Surgery · 28d
Cleared Mar 04, 1988
MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.
K880216
Directed Energy, Inc.
General & Plastic Surgery · 44d
Cleared Feb 26, 1988
INFRAGUIDE(TM)
K875115
Cooper Lasersonics, Inc.
General & Plastic Surgery · 74d
Cleared Feb 05, 1988
MODEL 5202 MICROMANIPULATOR
K874811
Coherent Medical Group
General & Plastic Surgery · 77d
Cleared Feb 04, 1988
COHERENT XA-30/SP CO2 SURGICAL LASER
K874648
Coherent Medical Group
General & Plastic Surgery · 83d
Cleared Jan 22, 1988
MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY
K873790
Cooper Lasersonics, Inc.
General & Plastic Surgery · 126d
Cleared Jan 06, 1988
ULTRASPOT MICROMANIPULATOR
K873443
Cooper Lasersonics, Inc.
General & Plastic Surgery · 132d