Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hoya Conbio, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
293 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083899 | REVLITE Q-SWITCHED ND:YAG LASER SYSTEM | Hoya Conbio, Inc. | 2009-06-01 | 154 | 0 |
| K073158 | SCULPTURE 2.94 ER:YAG SYSTEM | Hoya Conbio, Inc. | 2008-08-27 | 293 | 0 |
| K073332 | V-RASER DIODE LASER SYSTEM | Hoya Conbio, Inc. | 2008-02-14 | 79 | 0 |
| K063384 | DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 | Hoya Conbio, Inc. | 2007-03-16 | 128 | 0 |
| K063834 | REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM | Hoya Conbio, Inc. | 2007-01-25 | 30 | 0 |
| K063112 | REVLITE Q-SWITCHED ND:YAG LASER | Hoya Conbio, Inc. | 2006-12-01 | 51 | 0 |
| K060977 | MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT A | Hoya Conbio, Inc. | 2006-05-24 | 44 | 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