Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Topcon Medical Laser Systems, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
189 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinS | Topcon Medical Laser Systems, Inc. | 2018-05-25 | 100 | 0 |
| K171488 | PSLT for PASCAL Streamline | Topcon Medical Laser Systems, Inc. | 2017-11-27 | 189 | 0 |
| K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER | Topcon Medical Laser Systems, Inc. | 2013-05-15 | 177 | 0 |
| K111108 | PASCAL STREAMLINE 577 (WITH ACCESSORIES) | Topcon Medical Laser Systems, Inc. | 2011-08-11 | 113 | 0 |
| K092621 | PASCAL STREAMLINE PHOTOCOAGULATOR | Topcon Medical Laser Systems, Inc. | 2009-09-25 | 30 | 0 |
| K043486 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 | Topcon Medical Laser Systems, Inc. | 2005-03-03 | 76 | 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