The following data is part of a premarket notification filed by Contamac Ltd. with the FDA for Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses.
| Device ID | K212631 |
| 510k Number | K212631 |
| Device Name: | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | Contamac Ltd. Carlton House Shire Hill Saffron Walden, GB Cb11 3au |
| Contact | Rob Mcgregor |
| Correspondent | Bret Andre EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-19 |
| Decision Date | 2022-03-17 |