Directed Energy, Inc.
Walker, MI, US
Directed Energy, Inc. appears in FDA device records in Walker, MI. FDA records list 39 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 39
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 39 510(k) clearances for Directed Energy, Inc. between 1984 and 1991. The busiest year on record is 1986, with 15. The most recent is 1991, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 15 |
| 1987 | 14 |
| 1988 | 6 |
| 1990 | 1 |
| 1991 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K904930 | SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH | GEX | Substantially Equivalent | |
| K894241 | MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT | GEX | Substantially Equivalent | |
| K883738 | CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. | GEX | Substantially Equivalent | |
| K882926 | MODEL AU-1 ACCESSORY UNIT | GEX | Substantially Equivalent | |
| K880216 | MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. | GEX | Substantially Equivalent | |
| K873331 | ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG | HRX | Substantially Equivalent | |
| K872709 | MODEL 20-C, RL-20A/U, OB-10A/U | HHR | Substantially Equivalent | |
| K870841 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN | HHR | Substantially Equivalent | |
| K872711 | MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY | GEX | Substantially Equivalent | |
| K872710 | MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT | EWG | Substantially Equivalent | |
| K870840 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH | EWG | Substantially Equivalent | |
| K870971 | MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT | GEX | Substantially Equivalent | |
| K870970 | MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT | GEX | Substantially Equivalent | |
| K870838 | MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE | GEX | Substantially Equivalent | |
| K870837 | MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE | GEX | Substantially Equivalent | |
| K870839 | MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC | HQF | Substantially Equivalent | |
| K871032 | MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO. | LNK | Substantially Equivalent | |
| K871029 | MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO. | LNK | Substantially Equivalent | |
| K871031 | 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH | LNK | Substantially Equivalent | |
| K871030 | MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO. | LNK | Substantially Equivalent | |
| K862866 | MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE | EWG | Substantially Equivalent | |
| K862865 | MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE | EWG | Substantially Equivalent | |
| K862861 | SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE | HHR | Substantially Equivalent | |
| K862864 | MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY | GEX | Substantially Equivalent | |
| K862863 | MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE | GEX | Substantially Equivalent | |
| K862408 | MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG | GEX | Substantially Equivalent | |
| K862422 | MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY | GEX | Substantially Equivalent | |
| K862862 | MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY | GEX | Substantially Equivalent | |
| K862423 | MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY | GEX | Substantially Equivalent | |
| K862150 | MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) | EWG | Substantially Equivalent for Some Indications | |
| K861845 | MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE | HHR | Substantially Equivalent | |
| K855210 | SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT | GEX | Substantially Equivalent | |
| K854998 | SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC | GEX | Substantially Equivalent | |
| K854386 | MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM | GEX | Substantially Equivalent | |
| K854399 | MODEL 20-B CO2 LASER SYSTEM | GEX | Substantially Equivalent | |
| K854398 | MODEL CO2 LASER SYSTEM 8B | GEX | Substantially Equivalent | |
| K854387 | MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM | GEX | Substantially Equivalent | |
| K853319 | MINI-HALO(HAND-HELD) CO2 LASER SYSTEM | GEX | Substantially Equivalent | |
| K841234 | HALO CO LASER SYSTEM | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain