TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR
FDA 510(k) clearance K052507 · decided 2005-11-02
Clearance details
- K-number
- K052507
- Device name
- TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR
- Applicant
- The Lagado Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-13
- Decision date
- 2005-11-02
- Days to decision
- 50 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
+ Add to Predicate Builder ◉ Watch The Lagado Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
|---|---|---|
| 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 |