Aspect Vision Care, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Aspect Vision Care, Ltd.” (first 1997, latest 1999), across 1 product code in 1 review panel. Median 510(k) review time under this name: 61 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 |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 5 | 5 |
Review panels
- Ophthalmic (5)
Most recent Aspect Vision Care, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982997 | FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER) | LPL | 1999-01-20 | 146 |
| K980634 | FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | LPL | 1998-04-22 | 62 |
| K973063 | FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR | LPL | 1997-08-26 | 8 |
| K971164 | FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS | LPL | 1997-05-21 | 51 |
| K971049 | FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | LPL | 1997-05-21 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named Aspect Vision Care, Ltd..
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.
- Aspect Medical Systems, Inc. (25 510(k)s)
- Aspect Imaging, Ltd. (6 510(k)s)
- Aspect Electronics, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aspect Vision Care, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Aspect Vision Care, Ltd.” (first 1997, latest 1999), across 1 product code 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 Aspect Vision Care, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aspect Vision Care, Ltd. is 61 days.
Which FDA product codes appear under Aspect Vision Care, Ltd.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 5).
Next steps
- See all 5 Aspect Vision Care, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Aspect Vision Care, Ltd.'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.