WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS
FDA premarket approval P810005/S013 · decided 1985-11-18
Approval details
- PMA number
- P810005
- Supplement
- S013
- Trade name
- WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Ciba Vision Care
- Date received
- 1985-05-07
- Decision date
- 1985-11-18
- Days to decision
- 195 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Duluth, GA
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PROFESSIONAL DISINFECTION SYSTEM (PDS) (K863346) | Ciba Vision Care | 1987-02-27 |
| IN A WINK LUBRICATING & REWETTING DROPS (K853445) | Ciba Vision Care | 1985-11-29 |