CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,
FDA 510(k) clearance K150590 · decided 2015-07-10
Clearance details
- K-number
- K150590
- Device name
- CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,
- Applicant
- Contamac, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-09
- Decision date
- 2015-07-10
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- 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.
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 |