ULTRA (samfilcon A) Visibility Tinted Soft Contact Lenses
FDA premarket approval P170035/S018 · decided 2025-09-15
Approval details
- PMA number
- P170035
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ULTRA (samfilcon A) Visibility Tinted Soft Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch and Lomb, Inc.,
- Date received
- 2025-08-20
- Decision date
- 2025-09-15
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- implement concentration control tanks in manufacturing lines to reduce the IPA usage concentration at Bausch + Lombs manufacturing facility located in Rochester, NY
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Easy-Load Lens Delivery System (K161012) | Bausch and Lomb, Inc., | 2016-07-06 |