Medical Device Manufacturer · US , Walker , MI

Directed Energy, Inc.

39 submissions · 38 cleared · Since 1984
39
Total
38
Cleared
0
Denied

Directed Energy, Inc. — FDA 510(k) Submissions

Directed Energy, Inc. has submitted 39 FDA 510(k) premarket notifications since 1984, of which 38 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powered Laser Surgical Instrument, Laser, Ent Microsurgical Carbon-dioxide, Laser, Surgical, Gynecologic, Laser For Gastro-urology Use, Laser, Ophthalmic . Use the specialty filter in the sidebar to narrow results.

39 devices
1–25 of 39
SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH
K904930 · GEX Powered Laser Surgical... · General & Plastic Surgery
Mar 1991 141d
MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT
K894241 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jun 1990 362d
CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.
K883738 · GEX Powered Laser Surgical... · General & Plastic Surgery
Nov 1988 75d
MODEL AU-1 ACCESSORY UNIT
K882926 · GEX Powered Laser Surgical... · General & Plastic Surgery
Sep 1988 58d
MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.
K880216 · GEX Powered Laser Surgical... · General & Plastic Surgery
Mar 1988 44d
ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG
K873331 · HRX Arthroscope · Orthopedic
Feb 1988 182d
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
K870841 · HHR Laser, Surgical, Gynecologic · Obstetrics & Gynecology
Feb 1988 341d
MODEL 20-C, RL-20A/U, OB-10A/U
K872709 · HHR Laser, Surgical, Gynecologic · Obstetrics & Gynecology
Feb 1988 210d
MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY
K872711 · GEX Powered Laser Surgical... · General & Plastic Surgery
Sep 1987 83d
MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT
K872710 · EWG Laser, Ent Microsurgical... · Ear, Nose, Throat
Sep 1987 79d
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH
K870840 · EWG Laser, Ent Microsurgical... · Ear, Nose, Throat
Jun 1987 106d
MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE
K870837 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 1987 89d
MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE
K870838 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 1987 89d
MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT
K870970 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 1987 77d
MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT
K870971 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 1987 77d
MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC
K870839 · HQF Laser, Ophthalmic · Ophthalmic
May 1987 86d
MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.
K871029 · LNK Laser For Gastro-urology Use · Gastroenterology & Urology
May 1987 63d
MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.
K871032 · LNK Laser For Gastro-urology Use · Gastroenterology & Urology
May 1987 63d
MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.
K871030 · LNK Laser For Gastro-urology Use · Gastroenterology & Urology
May 1987 60d
10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH
K871031 · LNK Laser For Gastro-urology Use · Gastroenterology & Urology
May 1987 60d
MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE
K862865 · EWG Laser, Ent Microsurgical... · Ear, Nose, Throat
Jan 1987 164d
MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE
K862866 · EWG Laser, Ent Microsurgical... · Ear, Nose, Throat
Jan 1987 164d
SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
K862861 · HHR Laser, Surgical, Gynecologic · Obstetrics & Gynecology
Oct 1986 90d
MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG
K862408 · GEX Powered Laser Surgical... · General & Plastic Surgery
Oct 1986 121d
MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE
K862863 · GEX Powered Laser Surgical... · General & Plastic Surgery
Oct 1986 87d
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