Refractec, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Refractec, Inc.” (first 1998, latest 2006), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 120 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 |
|---|---|---|---|
| HMR | Marker, Ocular | 1 | 1 |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | 1 | 1 |
| MWD | Electrosurgical, Radio Frequency, Refractive Correction | 1 | 0 |
Review panels
- Ophthalmic (3)
Most recent Refractec, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053475 | OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 | HMR | 2006-03-03 | 79 |
| K980522 | REFRACTEC MCS-100 | HQR | 1998-07-22 | 162 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P010018 | PMA | VIEWPOINT(TM) CK SYSTEM | 2002-04-11 |
Recalls
openFDA lists no recalls under a recalling firm named Refractec, 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 Refractec, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Refractec, Inc.” (first 1998, latest 2006), plus 1 PMA decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Refractec, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Refractec, Inc. is 120 days.
Which FDA product codes appear under Refractec, Inc.?
The most frequent FDA product codes under this applicant name are HMR (Marker, Ocular, 1); HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered, 1); MWD (Electrosurgical, Radio Frequency, Refractive Correction, 1).
Next steps
- See all 2 Refractec, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HMR, Refractec, 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.