Continuum Electro-Optics, Inc.: FDA clearances and approvals
Continuum Electro-Optics, Inc. has 7 FDA 510(k) clearances (first 1994, latest 2003), across 1 product code in 1 review panel. Median 510(k) review time: 89 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 7 | 7 |
Review panels
Most recent Continuum Electro-Optics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022709 | MEDLITE Q-SWITHCED LASER | GEX | 2003-02-20 | 190 |
| K022351 | DIODENT DENTAL LASER SYSTEM | GEX | 2002-10-16 | 89 |
| K021616 | DELIGHT DENTAL ER: YAG LASER SYSTEM | GEX | 2002-07-11 | 56 |
| K013216 | DIODENT DENTAL LASER SYSTEM | GEX | 2002-02-27 | 154 |
| K014234 | MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER | GEX | 2002-01-17 | 22 |
| K011677 | MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER | GEX | 2001-06-22 | 23 |
| K933057 | MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM | GEX | 1994-11-01 | 497 |
Recalls
openFDA lists no recalls under a recalling firm named Continuum Electro-Optics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Continuum Electro-Optics, Inc. have?
Continuum Electro-Optics, Inc. has 7 FDA 510(k) clearances (first 1994, latest 2003), across 1 product code in 1 review panel.
How long does FDA take to clear Continuum Electro-Optics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Continuum Electro-Optics, Inc.'s cleared 510(k)s is 89 days.
What devices does Continuum Electro-Optics, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 7).
Has Continuum Electro-Optics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Continuum Electro-Optics, Inc. Related entities may recall under other names.
Next steps
- See all 7 Continuum Electro-Optics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Continuum Electro-Optics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.