Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Continuum Electro-Optics, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
497 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022709 | MEDLITE Q-SWITHCED LASER | Continuum Electro-Optics, Inc. | 2003-02-20 | 190 | 0 |
| K022351 | DIODENT DENTAL LASER SYSTEM | Continuum Electro-Optics, Inc. | 2002-10-16 | 89 | 0 |
| K021616 | DELIGHT DENTAL ER: YAG LASER SYSTEM | Continuum Electro-Optics, Inc. | 2002-07-11 | 56 | 0 |
| K013216 | DIODENT DENTAL LASER SYSTEM | Continuum Electro-Optics, Inc. | 2002-02-27 | 154 | 0 |
| K014234 | MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 | Continuum Electro-Optics, Inc. | 2002-01-17 | 22 | 0 |
| K011677 | MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q | Continuum Electro-Optics, Inc. | 2001-06-22 | 23 | 0 |
| K933057 | MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM | Continuum Electro-Optics, Inc. | 1994-11-01 | 497 | 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