N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL
FDA premarket approval P880024/S002 · decided 1994-02-24
Approval details
- PMA number
- P880024
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL
- Generic name
- Lens, contact (other material) - daily
- Applicant
- The Lagado Corp.
- Date received
- 1993-03-05
- Decision date
- 1994-02-24
- Days to decision
- 356 days
- Decision code
- APPR
- Product code
- HQD
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Englewood, CO
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE (K120756) | The Lagado Corp. | 2013-05-13 |
| PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS (K130285) | The Lagado Corp. | 2013-04-03 |
| TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS (K102154) | The Lagado Corp. | 2011-01-21 |
| TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR (K052507) | The Lagado Corp. | 2005-11-02 |
| ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS (K033599) | The Lagado Corp. | 2004-09-16 |