ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
FDA 510(k) clearance K091327 · decided 2010-06-25
Clearance details
- K-number
- K091327
- Device name
- ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
- Applicant
- Alden Optical Labs., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-05-05
- Decision date
- 2010-06-25
- Days to decision
- 416 days
- Clearance type
- Special
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Alden, NY, 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 |
|---|---|---|
| AL-47 SOFT CONTACT LENS (P820078) | Alden Optical Labs., Inc. | 1984-01-30 |