Ciba Vision Care: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Ciba Vision Care” (first 1985, latest 1987), plus 2 PMA decisions, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 144 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Alcon, based on public ownership records.
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 |
|---|---|---|---|
| LPM | Lenses, Soft Contact, Extended Wear | 2 | 0 |
| HPX | Lens, Contact (Polymethylmethacrylate) | 1 | 1 |
| LPN | Accessories, Soft Lens Products | 1 | 1 |
Review panels
- Ophthalmic (4)
Most recent Ciba Vision Care 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863346 | PROFESSIONAL DISINFECTION SYSTEM (PDS) | LPN | 1987-02-27 | 182 |
| K853445 | IN A WINK LUBRICATING & REWETTING DROPS | HPX | 1985-11-29 | 105 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P820086 | PMA | CIBATINT(TM) TINTING PROCESS | 1984-02-08 |
| P810005 | PMA | WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS | 1981-09-24 |
Recalls
openFDA lists no recalls under a recalling firm named Ciba Vision Care.
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.
- Ciba Corning Diagnostics Corp. (125 510(k)s)
- Ciba Vision Corporation (44 510(k)s)
- Ciba-Geigy Corp. (2 510(k)s)
- Ciba Vision Johns Creek Mfg. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ciba Vision Care?
FDA lists 2 510(k) clearances under the applicant name “Ciba Vision Care” (first 1985, latest 1987), plus 2 PMA decisions, 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 Ciba Vision Care?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ciba Vision Care is 144 days.
Which FDA product codes appear under Ciba Vision Care?
The most frequent FDA product codes under this applicant name are LPM (Lenses, Soft Contact, Extended Wear, 2); HPX (Lens, Contact (Polymethylmethacrylate), 1); LPN (Accessories, Soft Lens Products, 1).
Next steps
- See all 2 Ciba Vision Care clearances with predicates and recalls
- Run predicate analysis for product code LPM, Ciba Vision Care'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.