Atlas FDA

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

Photo Medex, Inc. · Predicate Candidate Screening

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

86 daysmedian FDA review time
90 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K082721LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMSPhoto Medex, Inc.2008-10-28411
K073659XTRAC ULTRA 2, MODEL AL10000Photo Medex, Inc.2008-03-05700
K051428VTRAC EXCIMER LAMP SYSTEMPhoto Medex, Inc.2005-08-09690
K041943XTRAC XL, MODEL AL8000Photo Medex, Inc.2004-10-14870
K040294LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980Photo Medex, Inc.2004-05-05890
K040234LASERPRO CO2 CARBON DIOXIDE LASER SYSTEMPhoto Medex, Inc.2004-04-02600
K031451XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000Photo Medex, Inc.2003-08-01860
K020847XTRAC EXCIMER LASER SYSTEM, MODEL AL7000Photo Medex, Inc.2002-05-16620
K011382XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000Photo Medex, Inc.2001-08-02870
K003705XTRAC EXCIMER LASER SYSTEM, MODEL AL7000Photo Medex, Inc.2001-03-01900

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