Ceram Optec, Inc.: FDA clearances and approvals
Ceram Optec, Inc. has 30 FDA 510(k) clearances (first 1992, latest 2000), across 3 product codes in 2 review panels. Median 510(k) review time: 88 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 | 27 | 27 |
| HQF | Laser, Ophthalmic | 2 | 2 |
| HLJ | Ophthalmoscope, Battery-Powered | 1 | 1 |
Review panels
Most recent Ceram Optec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002296 | CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 | GEX | 2000-10-02 | 66 |
| K001975 | CERALAS D10 810NM LASER, MODEL CERALAS D10-60 | GEX | 2000-08-04 | 36 |
| K993911 | CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 | GEX | 2000-02-01 | 77 |
| K993828 | CERALAS D10 810NM DIODE LASER | GEX | 2000-02-01 | 81 |
| K993002 | CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 | GEX | 1999-10-14 | 37 |
| K992773 | CERALAS D10 810NM DIODE LASER | GEX | 1999-09-01 | 14 |
| K991891 | CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15 | GEX | 1999-06-24 | 21 |
| K983950 | CERALAS DIODE LASER SYSTEM (MODEL H) | GEX | 1999-02-03 | 90 |
| K983058 | CERALAS D LASER SYSTEM, MODEL # CERALAS D15 | GEX | 1998-10-21 | 50 |
| K980389 | MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES | GEX | 1998-07-29 | 177 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ceram Optec, 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 Ceram Optec, Inc. have?
Ceram Optec, Inc. has 30 FDA 510(k) clearances (first 1992, latest 2000), across 3 product codes in 2 review panels.
How long does FDA take to clear Ceram Optec, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ceram Optec, Inc.'s cleared 510(k)s is 88 days.
What devices does Ceram Optec, Inc. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 27); HQF (Laser, Ophthalmic, 2); HLJ (Ophthalmoscope, Battery-Powered, 1).
Has Ceram Optec, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ceram Optec, Inc. Related entities may recall under other names.
Next steps
- See all 30 Ceram Optec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Ceram Optec, 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.