Directed Energy, Inc. - FDA 510(k) Cleared Devices
39
Total
38
Cleared
0
Denied
39 devices
Cleared
Oct 24, 1986
MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY
General & Plastic Surgery
87d
Cleared
Oct 02, 1986
MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY
General & Plastic Surgery
99d
Cleared
Sep 19, 1986
MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY
General & Plastic Surgery
52d
Cleared
Sep 15, 1986
MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY
General & Plastic Surgery
82d
Cleared
Sep 04, 1986
MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)
Ear, Nose, Throat
92d
Cleared
Aug 11, 1986
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
Obstetrics & Gynecology
90d
Cleared
May 02, 1986
SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC
General & Plastic Surgery
141d
Cleared
May 02, 1986
SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT
General & Plastic Surgery
123d
Cleared
Mar 28, 1986
MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM
General & Plastic Surgery
148d
Cleared
Feb 07, 1986
MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM
General & Plastic Surgery
99d
Cleared
Feb 07, 1986
MODEL CO2 LASER SYSTEM 8B
General & Plastic Surgery
99d
Cleared
Feb 07, 1986
MODEL 20-B CO2 LASER SYSTEM
General & Plastic Surgery
99d
Cleared
Sep 19, 1985
MINI-HALO(HAND-HELD) CO2 LASER SYSTEM
General & Plastic Surgery
43d
Cleared
Jul 09, 1984
HALO CO LASER SYSTEM
General & Plastic Surgery
109d