Optimum Infinite (tisilfocon A) Orthokeratology Lenses II
FDA premarket approval P240045 · decided 2026-02-10
Approval details
- PMA number
- P240045
- Trade name
- Optimum Infinite (tisilfocon A) Orthokeratology Lenses II
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Contamac, Ltd.
- Date received
- 2024-12-17
- Decision date
- 2026-02-10
- Days to decision
- 420 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Saffron Walden
- Statement
- Approval for Optimum Infinite (tisilfocon A) Ortho-k Lenses, Optimum Infinite (tisilfocon A) Orthokeratology Lenses II.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses (K212631) | Contamac, Ltd. | 2022-03-17 |
| Hyper GP (tisilfocon A) Daily Wear Contact Lens (K182304) | Contamac, Ltd. | 2018-11-23 |
| Nutrifill (K181566) | Contamac, Ltd. | 2018-10-22 |
| OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens (K180616) | Contamac, Ltd. | 2018-04-25 |
| ENFLU 18 (enflufocon A) Daily Wear Contact Lens (K171575) | Contamac, Ltd. | 2017-10-24 |
| HEXA100 (hexafocon A) Daily Wear Contact Lenses (K171077) | Contamac, Ltd. | 2017-08-01 |
| Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses (K161100) | Contamac, Ltd. | 2016-08-10 |
| OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (K160859) | Contamac, Ltd. | 2016-07-13 |