Medical Device Manufacturer · US , Walker , MI

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

39 submissions · 38 cleared · Since 1984

39

Total

38

Cleared

0

Denied

FDA 510(k) Regulatory Record - Directed Energy, Inc. General & Plastic Surgery ✕

24 devices

1-12 of 24

Cleared Mar 21, 1991

SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH

General & Plastic Surgery · 141d

Cleared Jun 18, 1990

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

General & Plastic Surgery · 362d

Cleared Nov 15, 1988

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

General & Plastic Surgery · 75d

Cleared Sep 09, 1988

MODEL AU-1 ACCESSORY UNIT

General & Plastic Surgery · 58d

Cleared Mar 04, 1988

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

General & Plastic Surgery · 44d

Cleared Sep 28, 1987

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

General & Plastic Surgery · 83d

Cleared May 26, 1987

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

General & Plastic Surgery · 89d

Cleared May 26, 1987

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

General & Plastic Surgery · 89d

Cleared May 26, 1987

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

General & Plastic Surgery · 77d

Cleared May 26, 1987

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

General & Plastic Surgery · 77d

Cleared Oct 24, 1986

MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG

General & Plastic Surgery · 121d

Cleared Oct 24, 1986

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

General & Plastic Surgery · 87d