OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
FDA 510(k) clearance K160859 · decided 2016-07-13
Clearance details
- K-number
- K160859
- Device name
- OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
- Applicant
- Contamac, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-29
- Decision date
- 2016-07-13
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- MUW
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Saffron Walden, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses (K183200) | C&E GP Specialist, Inc. | 2019-01-09 |
| FLUOROPERM 151-OK, PARAGON HDS 100-OK (K010109) | Paragon Vision Sciences | 2001-02-28 |
| BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY (K003933) | Polymer Technology | 2001-02-16 |
| FLUROPERM 60-OK, PARAGON HDS-OK (K000224) | Paragon Vision Sciences | 2000-04-17 |
| AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY (K973697) | Airperm, Inc. | 1998-04-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IGEL 67 CONTACT LENS (P860009/S002) | Contamac, Ltd. | 1989-05-09 |
| IDEL 67 CONTACT LENS (P860009/S001) | Contamac, Ltd. | 1987-10-13 |