Atlas FDA

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

Laser Photonics, Inc. — Predicate Candidate Screening

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

157 daysmedian FDA review time
350 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K934501LASER PHOTONICS ML755 DERMABLASERLaser Photonics, Inc.1994-08-303500
K933140RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEMLaser Photonics, Inc.1994-03-022470
K924537LPI ML210 HOLMIUM SURGICAL LASERLaser Photonics, Inc.1993-04-072150
K920334LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH.Laser Photonics, Inc.1993-03-314290
K915631LPI ML 100/532 AND ML 532 SURGICAL LASERLaser Photonics, Inc.1992-06-151810
K914827LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATIONLaser Photonics, Inc.1992-03-271570
K904841LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIEDLaser Photonics, Inc.1991-04-191770
K910233LASER PHOTONICS ML-210 HOLMIUM:YAG MEDI LASE SYSTLaser Photonics, Inc.1991-04-12840
K904354LPI MULILASE YAG/532 SURGICAL LASER SYSTEMLaser Photonics, Inc.1990-12-19860
K904331L.P.I. LASER DELIVERY SYSTEMLaser Photonics, Inc.1990-12-17870
K904227MULTILASE 45Laser Photonics, Inc.1990-12-12900
K904229MULTILASE 60Laser Photonics, Inc.1990-12-12900
K900837LPI YAG MODEL 1003 SURGICAL LASER SYSTEMLaser Photonics, Inc.1990-07-121400
K882738L.P.I. LASER DELIVERY SYSTEMLaser Photonics, Inc.1988-08-30600

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