Eyetech, LLC: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Eyetech, LLC” (first 1984, latest 1984), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 84 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 |
|---|---|---|---|
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| HQL | Intraocular Lens | 1 | 0 |
Review panels
- Ophthalmic (2)
Most recent Eyetech, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843354 | EPISCLERAL VENOUS PRESSURE | HKX | 1984-11-19 | 84 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P880082 | PMA | MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES | 1990-06-13 |
Recalls
openFDA lists no recalls under a recalling firm named Eyetech, LLC.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Eyetech M.V.A. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Eyetech, LLC?
FDA lists 1 510(k) clearance under the applicant name “Eyetech, LLC” (first 1984, latest 1984), plus 1 PMA decision, across 2 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 Eyetech, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eyetech, LLC is 84 days.
Which FDA product codes appear under Eyetech, LLC?
The most frequent FDA product codes under this applicant name are HKX (Tonometer, Ac-Powered, 1); HQL (Intraocular Lens, 1).
Next steps
- See all 1 Eyetech, LLC clearances with predicates and recalls
- Run predicate analysis for product code HKX, Eyetech, LLC'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.