Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A.R.C. Laser AG — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003512 | LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II | A.R.C. Laser AG | 2001-02-08 | 86 | 0 |
| K002986 | A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 | A.R.C. Laser AG | 2000-11-29 | 65 | 0 |
| K001511 | O-LAS OPHTHALMIC PHOTODISRUPTOR | A.R.C. Laser AG | 2000-07-19 | 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