Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Johnson & Johnson Surgical Vision, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223566 | ELITA™ Femtosecond Laser System, ELITA™ Patient Interface | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 | 136 | 0 |
| K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidi | Johnson & Johnson Surgical Vision, Inc. | 2021-03-12 | 155 | 3 |
| K191949 | UNFOLDER Vitan Inserter | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 | 53 | 0 |
| K191933 | COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Co | Johnson & Johnson Surgical Vision, Inc. | 2019-08-16 | 28 | 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