Atlas FDA

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

Laser Media — Predicate Candidate Screening

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

70 daysmedian FDA review time
177 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K872352FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIALaser Media1987-12-301960
K872351FIBERLASE II ND:YAG LASER FOR PULMONARY USELaser Media1987-12-111770
K872350FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USELaser Media1987-08-10540
K872031UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEMLaser Media1987-08-04700
K863428SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAGLaser Media1986-12-03900
K863583CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASERLaser Media1986-11-24760
K862444FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIALaser Media1986-09-25910
K860063ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEMLaser Media1986-02-05300
K855197FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEMLaser Media1986-01-21260
K852798FIBERLASE 100 MEDICAL LASER SYSTEMLaser Media1985-07-29280
K850509ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEMLaser Media1985-04-08590
K844869FIBERLASE 100 MEDICAL LASER SYSTEMLaser Media1985-01-14310

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