Company ยท US
Directed Energy, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1991. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 1991 | K904930 | SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH Directed Energy, Inc. | GEX |
| Jun 18, 1990 | K894241 | MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT Directed Energy, Inc. | GEX |
| Nov 15, 1988 | K883738 | CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. Directed Energy, Inc. | GEX |
| Sep 9, 1988 | K882926 | MODEL AU-1 ACCESSORY UNIT Directed Energy, Inc. | GEX |
| Mar 4, 1988 | K880216 | MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. Directed Energy, Inc. | GEX |
| Feb 17, 1988 | K873331 | ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG Directed Energy, Inc. | HRX |
| Feb 2, 1988 | K872709 | MODEL 20-C, RL-20A/U, OB-10A/U Directed Energy, Inc. | HHR |
| Feb 2, 1988 | K870841 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN Directed Energy, Inc. | HHR |
| Sep 28, 1987 | K872711 | MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY Directed Energy, Inc. | GEX |
| Sep 24, 1987 | K872710 | MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT Directed Energy, Inc. | EWG |
| Jun 12, 1987 | K870840 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH Directed Energy, Inc. | EWG |
| May 26, 1987 | K870971 | MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT Directed Energy, Inc. | GEX |
| May 26, 1987 | K870970 | MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT Directed Energy, Inc. | GEX |
| May 26, 1987 | K870838 | MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE Directed Energy, Inc. | GEX |
| May 26, 1987 | K870837 | MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE Directed Energy, Inc. | GEX |
| May 22, 1987 | K870839 | MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC Directed Energy, Inc. | HQF |
| May 18, 1987 | K871032 | MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO. Directed Energy, Inc. | LNK |
| May 18, 1987 | K871029 | MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO. Directed Energy, Inc. | LNK |
| May 15, 1987 | K871031 | 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH Directed Energy, Inc. | LNK |
| May 15, 1987 | K871030 | MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO. Directed Energy, Inc. | LNK |
| Jan 9, 1987 | K862866 | MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE Directed Energy, Inc. | EWG |
| Jan 9, 1987 | K862865 | MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE Directed Energy, Inc. | EWG |
| Oct 27, 1986 | K862861 | SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE Directed Energy, Inc. | HHR |
| Oct 24, 1986 | K862864 | MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY Directed Energy, Inc. | GEX |
| Oct 24, 1986 | K862863 | MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE Directed Energy, Inc. | GEX |
| Oct 24, 1986 | K862408 | MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG Directed Energy, Inc. | GEX |
| Oct 2, 1986 | K862422 | MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY Directed Energy, Inc. | GEX |
| Sep 19, 1986 | K862862 | MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY Directed Energy, Inc. | GEX |
| Sep 15, 1986 | K862423 | MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY Directed Energy, Inc. | GEX |
| Sep 4, 1986 | K862150 | MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) Directed Energy, Inc. | EWG |
| Aug 11, 1986 | K861845 | MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE Directed Energy, Inc. | HHR |
| May 2, 1986 | K855210 | SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT Directed Energy, Inc. | GEX |
| May 2, 1986 | K854998 | SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC Directed Energy, Inc. | GEX |
| Mar 28, 1986 | K854386 | MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM Directed Energy, Inc. | GEX |
| Feb 7, 1986 | K854399 | MODEL 20-B CO2 LASER SYSTEM Directed Energy, Inc. | GEX |
| Feb 7, 1986 | K854398 | MODEL CO2 LASER SYSTEM 8B Directed Energy, Inc. | GEX |
| Feb 7, 1986 | K854387 | MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM Directed Energy, Inc. | GEX |
| Sep 19, 1985 | K853319 | MINI-HALO(HAND-HELD) CO2 LASER SYSTEM Directed Energy, Inc. | GEX |
| Jul 9, 1984 | K841234 | HALO CO LASER SYSTEM Directed Energy, Inc. | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||