TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS
FDA premarket approval P870079/S003 · decided 1990-03-29
Approval details
- PMA number
- P870079
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- United Contact Lens, Inc.
- Date received
- 1989-08-03
- Decision date
- 1990-03-29
- Days to decision
- 238 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Everett, WA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| 55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K051184) | United Contact Lens, Inc. | 2005-07-01 |
| UCL MULTIFOCAL SOFT CONTACT LENS (K941607) | United Contact Lens, Inc. | 1994-06-06 |