Phakosystems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Phakosystems, Inc.” (first 1983, latest 1988), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HOC | Clip, Iris Retractor | 1 | 1 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
Review panels
- Ophthalmic (2)
- Radiology (2)
- General and Plastic Surgery (1)
Most recent Phakosystems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880081 | VISION CARE/PHAKOSYSTEMS ECHOPACH | IYO | 1988-03-15 | 64 |
| K871938 | VISION CARE/PHAKOSYSTEMS ECHORULE | IYO | 1987-11-23 | 189 |
| K860236 | PHAKOSYSTEMS CT-100 CAUTERY MODULE | GEI | 1986-02-19 | 27 |
| K851674 | PHAKOSYSTEMS MODEL CES 4100 | HQC | 1985-08-05 | 104 |
| K830871 | PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION | HOC | 1983-06-02 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named Phakosystems, 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 Phakosystems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Phakosystems, Inc.” (first 1983, latest 1988), across 4 product codes in 3 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 Phakosystems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phakosystems, Inc. is 76 days.
Which FDA product codes appear under Phakosystems, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 2); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1); HOC (Clip, Iris Retractor, 1).
Next steps
- See all 5 Phakosystems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Phakosystems, 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.