Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses
FDA premarket approval P170035/S009 · decided 2020-09-28
Approval details
- PMA number
- P170035
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch and Lomb, Inc.,
- Date received
- 2020-09-02
- Decision date
- 2020-09-28
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Qualification of an additional manufacturer of a raw material for Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses and Bausch + Lomb PureVision (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses.
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 |
|---|---|---|
| Easy-Load Lens Delivery System (K161012) | Bausch and Lomb, Inc., | 2016-07-06 |