Ultra (samfilcon A) Contact Lens
FDA premarket approval P170035/S013 · decided 2021-08-27
Approval details
- PMA number
- P170035
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Ultra (samfilcon A) Contact Lens
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch and Lomb, Inc.,
- Date received
- 2021-06-03
- Decision date
- 2021-08-27
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Approval to remove the Sagittal Depth measurement acceptance criteria from the finished product specifications for Ultra (samfilcon A) Contact Lens.
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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 |