Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Directed Energy, Inc. — Predicate Candidate Screening

39 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time

182 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days
K904930	SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH	Directed Energy, Inc.	1991-03-21	141
K894241	MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT	Directed Energy, Inc.	1990-06-18	362
K883738	CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.	Directed Energy, Inc.	1988-11-15	75
K882926	MODEL AU-1 ACCESSORY UNIT	Directed Energy, Inc.	1988-09-09	58
K880216	MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.	Directed Energy, Inc.	1988-03-04	44
K873331	ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG	Directed Energy, Inc.	1988-02-17	182
K872709	MODEL 20-C, RL-20A/U, OB-10A/U	Directed Energy, Inc.	1988-02-02	210
K870841	MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN	Directed Energy, Inc.	1988-02-02	341
K872711	MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY	Directed Energy, Inc.	1987-09-28	83
K872710	MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT	Directed Energy, Inc.	1987-09-24	79
K870840	MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH	Directed Energy, Inc.	1987-06-12	106
K870970	MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT	Directed Energy, Inc.	1987-05-26	77
K870837	MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE	Directed Energy, Inc.	1987-05-26	89
K870971	MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT	Directed Energy, Inc.	1987-05-26	77
K870838	MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE	Directed Energy, Inc.	1987-05-26	89
K870839	MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC	Directed Energy, Inc.	1987-05-22	86
K871029	MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.	Directed Energy, Inc.	1987-05-18	63
K871032	MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.	Directed Energy, Inc.	1987-05-18	63
K871030	MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.	Directed Energy, Inc.	1987-05-15	60
K871031	10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH	Directed Energy, Inc.	1987-05-15	60
K862866	MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE	Directed Energy, Inc.	1987-01-09	164
K862865	MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE	Directed Energy, Inc.	1987-01-09	164
K862861	SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE	Directed Energy, Inc.	1986-10-27	90
K862863	MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE	Directed Energy, Inc.	1986-10-24	87
K862408	MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG	Directed Energy, Inc.	1986-10-24	121
K862864	MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY	Directed Energy, Inc.	1986-10-24	87
K862422	MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY	Directed Energy, Inc.	1986-10-02	99
K862862	MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY	Directed Energy, Inc.	1986-09-19	52
K862423	MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY	Directed Energy, Inc.	1986-09-15	82
K862150	MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)	Directed Energy, Inc.	1986-09-04	92
K861845	MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE	Directed Energy, Inc.	1986-08-11	90
K854998	SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC	Directed Energy, Inc.	1986-05-02	141
K855210	SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT	Directed Energy, Inc.	1986-05-02	123
K854386	MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM	Directed Energy, Inc.	1986-03-28	148
K854387	MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM	Directed Energy, Inc.	1986-02-07	99
K854399	MODEL 20-B CO2 LASER SYSTEM	Directed Energy, Inc.	1986-02-07	99
K854398	MODEL CO2 LASER SYSTEM 8B	Directed Energy, Inc.	1986-02-07	99
K853319	MINI-HALO(HAND-HELD) CO2 LASER SYSTEM	Directed Energy, Inc.	1985-09-19	43
K841234	HALO CO LASER SYSTEM	Directed Energy, Inc.	1984-07-09	109

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda