OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)
FDA 510(k) clearance K952260 · decided 1996-01-03
Clearance details
- K-number
- K952260
- Device name
- OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)
- Applicant
- Stellar Contact Lens, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-05-15
- Decision date
- 1996-01-03
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- HQD
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Chicago, IL, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OP-3 (TM) RGP CONTACT LENS (P920045/S001) | Stellar Contact Lens, Inc. | 1994-02-24 |