Medical Device Manufacturer · US , Walker , MI

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

39 submissions · 38 cleared · Since 1984

Recent clearances: SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH, MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT, CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.

39

Total

38

Cleared

0

Denied

FDA 510(k) Regulatory Record - Directed Energy, Inc. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared May 18, 1987

MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.

Gastroenterology & Urology · 63d

Cleared May 18, 1987

MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.

Gastroenterology & Urology · 63d

Cleared May 15, 1987

MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.

Gastroenterology & Urology · 60d

Cleared May 15, 1987

10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH

Gastroenterology & Urology · 60d