TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
FDA 510(k) clearance K102154 · decided 2011-01-21
Clearance details
- K-number
- K102154
- Device name
- TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
- Applicant
- The Lagado Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-30
- Decision date
- 2011-01-21
- Days to decision
- 175 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
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL (P880024/S003) | The Lagado Corp. | 1994-03-04 |
| N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL (P880024/S002) | The Lagado Corp. | 1994-02-24 |