Optimedica Corporation: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Optimedica Corporation” (first 2006, latest 2016), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 100 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 | 1 | 140 |
| 2013 | 0 | — |
| 2014 | 1 | 139 |
| 2015 | 0 | — |
| 2016 | 1 | 117 |
| 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 |
|---|---|---|---|
| OOE | Ophthalmic Femtosecond Laser | 4 | 4 |
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Review panels
Most recent Optimedica Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161455 | Catalys Precision Laser System | OOE | 2016-09-20 | 117 |
| K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | 2014-09-11 | 139 |
| K121091 | CATALYS PRECISION LASER SYSTEM | OOE | 2012-08-28 | 140 |
| K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | 2011-12-21 | 28 |
| K100019 | PASCAL STREAMLINE PHOTOCOAGULATOR | HQF | 2010-05-04 | 119 |
| K091666 | PASCAL PHOTOCOAGULATOR, PASCAL-US | GEX | 2009-07-15 | 36 |
| K081744 | PASCAL SYNTHESIS DELIVERY SYSTEM | GEX | 2008-09-09 | 82 |
| K062336 | OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE | GEX | 2006-10-19 | 70 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-02-20.
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 Optimedica Corporation?
FDA lists 8 510(k) clearances under the applicant name “Optimedica Corporation” (first 2006, latest 2016), 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 Optimedica Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Optimedica Corporation is 100 days.
Which FDA product codes appear under Optimedica Corporation?
The most frequent FDA product codes under this applicant name are OOE (Ophthalmic Femtosecond Laser, 4); GEX (Powered Laser Surgical Instrument, 3); HQF (Laser, Ophthalmic, 1).
Next steps
- See all 8 Optimedica Corporation clearances with predicates and recalls
- Run predicate analysis for product code OOE, Optimedica Corporation'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.