Ceram Optec, Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Ceram Optec, Inc.” (first 1992, latest 2000), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ceram Optec, Inc.?
FDA lists 30 510(k) clearances under the applicant name “Ceram Optec, Inc.” (first 1992, latest 2000), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ceram Optec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ceram Optec, Inc. is 88 days.
Which FDA product codes appear under Ceram Optec, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 27); HQF (Laser, Ophthalmic, 2); HLJ (Ophthalmoscope, Battery-Powered, 1).
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. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.