iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
FDA 510(k) clearance K183200 · decided 2019-01-09
Clearance details
- K-number
- K183200
- Device name
- iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
- Applicant
- C&E GP Specialist, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-19
- Decision date
- 2019-01-09
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- MUW
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- San Diego, CA, US
- 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 |
|---|---|---|
| OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (K160859) | Contamac, Ltd. | 2016-07-13 |
| 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.