Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LXS — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
252 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023045 | MICRORUPTER V | Meridian AG | 2002-09-26 | 14 | 0 |
| K901605 | PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. | Phoenix Laser Systems, Inc. | 1990-12-13 | 252 | 0 |
| K895864 | MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP | Lasag AG | 1989-12-29 | 87 | 0 |
| K893987 | NIDEK MODEL YC-1200 | Nidek, Inc. | 1989-08-18 | 74 | 1 |
| K892204 | NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS | Nidek, Inc. | 1989-06-22 | 80 | 0 |
| K892058 | ISL QC 2000 | Intelligent Surgical Lasers, Inc. | 1989-06-15 | 78 | 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