Contamac, Ltd.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Contamac, Ltd.” (first 2002, latest 2022), plus 1 PMA decision, across 5 product codes in 1 review panel. Median 510(k) review time under this name: 98 days. Since 2017 the median was 121 days, against 102 days for all cleared 510(k)s in the same product codes. 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 | 1 | 123 |
| 2016 | 2 | 110 |
| 2017 | 2 | 130 |
| 2018 | 3 | 91 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 210 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Contamac, Ltd. took a median 121 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | 11 | 11 |
| LPL | Lenses, Soft Contact, Daily Wear | 5 | 5 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | 1 | 1 |
| MUW | Lens, Contact (Orthokeratology) | 1 | 1 |
| NUU | Lens, Contact, Orthokeratology, Overnight | 1 | 0 |
Review panels
- Ophthalmic (19)
Most recent Contamac, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | HQD | 2022-03-17 | 210 |
| K182304 | Hyper GP (tisilfocon A) Daily Wear Contact Lens | HQD | 2018-11-23 | 91 |
| K181566 | Nutrifill | MRC | 2018-10-22 | 130 |
| K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens | HQD | 2018-04-25 | 48 |
| K171575 | ENFLU 18 (enflufocon A) Daily Wear Contact Lens | HQD | 2017-10-24 | 147 |
| K171077 | HEXA100 (hexafocon A) Daily Wear Contact Lenses | HQD | 2017-08-01 | 112 |
| K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | HQD | 2016-08-10 | 113 |
| K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | MUW | 2016-07-13 | 106 |
| K150590 | CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, | LPL | 2015-07-10 | 123 |
| K081178 | OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES | HQD | 2008-10-09 | 167 |
8 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P240045 | PMA | Optimum Infinite (tisilfocon A) Orthokeratology Lenses II | 2026-02-10 |
Recalls
openFDA lists no recalls under a recalling firm named Contamac, 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.
Device clinical trials
An industry sponsor named Contamac, Ltd. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03525704: Evaluation of Contact Lens Saline Solutions With Scleral GP Contact Lens Wearers Experiencing Fogging (Completed, started 2018-04-09)
- NCT02553681: Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D (Completed, started 2015-07)
- NCT02312323: One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses (Completed, started 2014-11-08)
- NCT01197859: Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens (Completed, started 2008-08)
Frequently asked questions
How many FDA 510(k) clearances are listed under Contamac, Ltd.?
FDA lists 18 510(k) clearances under the applicant name “Contamac, Ltd.” (first 2002, latest 2022), plus 1 PMA decision, across 5 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 Contamac, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Contamac, Ltd. is 98 days. Since 2017: 121 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Contamac, Ltd.?
The most frequent FDA product codes under this applicant name are HQD (Lens, Contact (Other Material) - Daily, 11); LPL (Lenses, Soft Contact, Daily Wear, 5); MRC (Products, Contact Lens Care, Rigid Gas Permeable, 1).
Next steps
- See all 18 Contamac, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HQD, Contamac, 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.