Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hoya Photonics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
210 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103118 | REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTO | Hoya Photonics, Inc. | 2010-11-19 | 29 | 1 |
| K050696 | MEDLITE C1 Q-SWITCHED ND:YAG LASER | Hoya Photonics, Inc. | 2005-06-17 | 91 | 0 |
| K050274 | DIODENT II DENTAL LASER SYSTEM | Hoya Photonics, Inc. | 2005-04-29 | 81 | 0 |
| K041721 | LVI AESTHETIC LASER | Hoya Photonics, Inc. | 2004-08-05 | 42 | 0 |
| K032797 | DELIGHT DENTAL ER: YAG LASER SYSTEM | Hoya Photonics, Inc. | 2004-04-05 | 210 | 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