Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ion Laser Technology — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
181 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974369 | APOLLO 9500 | Ion Laser Technology | 1998-01-06 | 47 | 0 |
| K964524 | ILT ARGON HP | Ion Laser Technology | 1997-03-18 | 126 | 0 |
| K953898 | ACL-5500 PRECISION CURING UNIT (PCU) | Ion Laser Technology | 1996-02-15 | 181 | 0 |
| K954460 | ILT SURGICAL LASER | Ion Laser Technology | 1995-12-18 | 84 | 0 |
| K950351 | CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MOD | Ion Laser Technology | 1995-03-24 | 53 | 0 |
| K944206 | GENESIS 2000 | Ion Laser Technology | 1994-10-11 | 43 | 0 |
| K944317 | GENESIS 2000 | Ion Laser Technology | 1994-10-11 | 43 | 0 |
| K915656 | CARBON DIOXIDE CO2 LASER | Ion Laser Technology | 1992-04-10 | 114 | 0 |
| K914726 | ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED | Ion Laser Technology | 1991-12-17 | 57 | 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