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

Luxar Corp. — Predicate Candidate Screening

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

57 daysmedian FDA review time

87 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K960475	MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM	Luxar Corp.	1996-04-26	85
K953074	MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM	Luxar Corp.	1995-08-28	59
K945888	MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEM	Luxar Corp.	1995-01-27	57
K904068	LUXAR MODEL LX-20 CO2 LASER	Luxar Corp.	1991-04-15	227
K903079	ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM)	Luxar Corp.	1990-10-04	84
K900066	FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER	Luxar Corp.	1990-03-19	74
K897040	LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.)	Luxar Corp.	1990-02-13	57
K896478	LUXAR MODEL LX-20 MINILASE CO2 LASER	Luxar Corp.	1990-02-08	87
K896595	LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE	Luxar Corp.	1990-01-09	49
K896619	LIST DERMATOLOGY/PLASTIC SURGERY AS USE ENDOGUIDE	Luxar Corp.	1990-01-09	49
K896711	LISTING PODIATRY AS INTENDED USE FOR ENDOGUIDE	Luxar Corp.	1990-01-09	42
K896618	LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE	Luxar Corp.	1990-01-09	49
K896617	LISTING ENT AS INTENDED USE FOR ENDOGUIDE	Luxar Corp.	1990-01-09	49
K895786	ENDOGUIDE PRODUCT LINE: EX0120, EX0300 AND EX0400	Luxar Corp.	1989-10-27	32
K895559	MODIFIED ENDOGUIDE	Luxar Corp.	1989-10-20	49
K893642	MODIFIED ENDOGUIDE	Luxar Corp.	1989-07-14	60
K884459	LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE	Luxar Corp.	1988-12-19	56

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