Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Laserguide — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
132 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880071 | SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE | Laserguide | 1988-03-22 | 71 | 0 |
| K873892 | SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE | Laserguide | 1988-02-02 | 132 | 0 |
| K875104 | SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE | Laserguide | 1988-02-02 | 46 | 0 |
| K873664 | LIGHT-SPOT FIBEROPTIC LASER HANDPIECE | Laserguide | 1987-11-06 | 57 | 0 |
| K873571 | LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE | Laserguide | 1987-11-06 | 65 | 0 |
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