Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cooltouch Corp. · 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) |
|---|---|---|---|---|---|
| K014035 | COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS | Cooltouch Corp. | 2002-03-07 | 90 | 0 |
| K010316 | COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:Y | Cooltouch Corp. | 2001-05-01 | 88 | 0 |
| K003715 | COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYS | Cooltouch Corp. | 2001-03-01 | 90 | 0 |
| K003781 | COOLTOUCH VARIA-II ND:YAG LASER SYSTEM | Cooltouch Corp. | 2000-12-20 | 13 | 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