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
39 devices
26-39 of 39
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 Sep 04, 1986
MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)
K862150 · EWG
Ear, Nose, Throat · 92d
Cleared Aug 11, 1986
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
K861845 · HHR
Obstetrics & Gynecology · 90d
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
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