Atlas FDA

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

Premier Laser Systems, Inc. — Predicate Candidate Screening

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

192 daysmedian FDA review time
1370 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K993285AURORA SLPremier Laser Systems, Inc.1999-11-18490
K992374AURORA HLPremier Laser Systems, Inc.1999-09-22690
K992620BLULAZEPremier Laser Systems, Inc.1999-08-20150
K981379AURORAPremier Laser Systems, Inc.1998-11-232210
K983211CENTAURIPremier Laser Systems, Inc.1998-10-09250
K980559PEGASUS ND:YAG LASER SYSTEMPremier Laser Systems, Inc.1998-08-241920
K974586AURORA DIODE LASER SYSTEMPremier Laser Systems, Inc.1998-07-152180
K980561DERMIUMPremier Laser Systems, Inc.1998-03-19340
K971118ARAGOPremier Laser Systems, Inc.1997-12-162700
K932683CENTAURIPremier Laser Systems, Inc.1997-05-0514320
K933841CENTAURIPremier Laser Systems, Inc.1997-05-0513700
K961682ARGON CURING LASERPremier Laser Systems, Inc.1996-08-151060
K954316AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIESPremier Laser Systems, Inc.1995-12-15910
K925178PEGASUSPremier Laser Systems, Inc.1994-03-145160

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