Directed Energy, Inc. - FDA 510(k) Cleared Devices

Cleared Mar 21, 1991

SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH

K904930 · GEX

General & Plastic Surgery · 141d

Cleared Jun 18, 1990

MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT

K894241 · GEX

General & Plastic Surgery · 362d

Cleared Nov 15, 1988

CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.

K883738 · GEX

General & Plastic Surgery · 75d

Cleared Sep 09, 1988

MODEL AU-1 ACCESSORY UNIT

K882926 · GEX

General & Plastic Surgery · 58d

Cleared Mar 04, 1988

MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.

K880216 · GEX

General & Plastic Surgery · 44d

Cleared Sep 28, 1987

MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY

K872711 · GEX

General & Plastic Surgery · 83d

Cleared May 26, 1987

MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE

K870837 · GEX

General & Plastic Surgery · 89d

Cleared May 26, 1987

MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE

K870838 · GEX

General & Plastic Surgery · 89d

Cleared May 26, 1987

MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT

K870970 · GEX

General & Plastic Surgery · 77d

Cleared May 26, 1987

MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT

K870971 · GEX

General & Plastic Surgery · 77d

Cleared Oct 24, 1986

MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG

K862408 · GEX

General & Plastic Surgery · 121d

Cleared Oct 24, 1986

MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE

K862863 · GEX

General & Plastic Surgery · 87d

Cleared Oct 24, 1986

MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY

K862864 · GEX

General & Plastic Surgery · 87d

Cleared Oct 02, 1986

MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY

K862422 · GEX

General & Plastic Surgery · 99d

Cleared Sep 19, 1986

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

K862862 · GEX

General & Plastic Surgery · 52d

Cleared Sep 15, 1986

MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY

K862423 · GEX

General & Plastic Surgery · 82d

Cleared May 02, 1986

SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC

K854998 · GEX

General & Plastic Surgery · 141d

Cleared May 02, 1986

SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT

K855210 · GEX

General & Plastic Surgery · 123d

Cleared Mar 28, 1986

MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM

K854386 · GEX

General & Plastic Surgery · 148d

Cleared Feb 07, 1986

MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM

K854387 · GEX

General & Plastic Surgery · 99d

Cleared Feb 07, 1986

MODEL CO2 LASER SYSTEM 8B

K854398 · GEX

General & Plastic Surgery · 99d

Cleared Feb 07, 1986

MODEL 20-B CO2 LASER SYSTEM

K854399 · GEX

General & Plastic Surgery · 99d

Cleared Sep 19, 1985

MINI-HALO(HAND-HELD) CO2 LASER SYSTEM

K853319 · GEX

General & Plastic Surgery · 43d

Cleared Jul 09, 1984

HALO CO LASER SYSTEM

K841234 · GEX

General & Plastic Surgery · 109d