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

2689–2712 of 2885

Cleared Oct 02, 1986

MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY

Directed Energy, Inc.

General & Plastic Surgery · 99d

Cleared Sep 19, 1986

MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY

Directed Energy, Inc.

General & Plastic Surgery · 52d

Cleared Sep 17, 1986

MODEL 8900 ND:YAG LASER

Cooper Lasersonics, Inc.

General & Plastic Surgery · 13d

Cleared Sep 15, 1986

MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY

Directed Energy, Inc.

General & Plastic Surgery · 82d

Cleared Aug 12, 1986

COOPER LASER SONICS ND: YAG LASER, MODEL 8008

Cooper Lasersonics, Inc.

General & Plastic Surgery · 383d

Cleared Jul 07, 1986

MODEL 545-45 LASER FOR DERMA., POD., SURGICAL

Britt Corp., Inc.

General & Plastic Surgery · 115d

Cleared Jun 18, 1986

ENDO-LASE CD40 FOR NEUROSURGERY

Endo Lase, Inc.

General & Plastic Surgery · 271d

Cleared May 02, 1986

ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY

Endo Lase, Inc.

General & Plastic Surgery · 227d

Cleared May 02, 1986

SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC

Directed Energy, Inc.

General & Plastic Surgery · 141d

Cleared May 02, 1986

SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT

Directed Energy, Inc.

General & Plastic Surgery · 123d

Cleared Apr 24, 1986

SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM

Sharplan Lasers, Inc.

General & Plastic Surgery · 105d

Cleared Apr 23, 1986

MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY

Britt Corp., Inc.

General & Plastic Surgery · 86d

Cleared Apr 15, 1986

MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC

Britt Corp., Inc.

General & Plastic Surgery · 78d

Cleared Mar 28, 1986

MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM

Directed Energy, Inc.

General & Plastic Surgery · 148d

Cleared Mar 21, 1986

AURORA M MEDICAL DYE LASER

Cooper Lasersonics, Inc.

General & Plastic Surgery · 91d

Cleared Feb 19, 1986

ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY

Endo Lase, Inc.

General & Plastic Surgery · 155d

Cleared Feb 19, 1986

ENDO-LASE CD 40 FOR DERMATOLOGY

Endo Lase, Inc.

General & Plastic Surgery · 152d

Cleared Feb 07, 1986

CODMAN LASER BACKSTOP

Codman & Shurtleff, Inc.

General & Plastic Surgery · 162d

Cleared Feb 07, 1986

CODMAN LASER RODS

Codman & Shurtleff, Inc.

General & Plastic Surgery · 162d

Cleared Feb 07, 1986

MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM

Directed Energy, Inc.

General & Plastic Surgery · 99d

Cleared Feb 07, 1986

MODEL CO2 LASER SYSTEM 8B

Directed Energy, Inc.

General & Plastic Surgery · 99d

Cleared Feb 07, 1986

MODEL 20-B CO2 LASER SYSTEM

Directed Energy, Inc.

General & Plastic Surgery · 99d

Cleared Nov 13, 1985

Surgilase, Inc.

General & Plastic Surgery · 155d

Cleared Oct 25, 1985

ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA-

Endo Lase, Inc.

General & Plastic Surgery · 38d