Eureka! Monthly (samfilcon A) Contact Lenses
FDA premarket approval P170035/S014 · decided 2022-01-24
Approval details
- PMA number
- P170035
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Eureka! Monthly (samfilcon A) Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch and Lomb, Inc.,
- Date received
- 2021-07-29
- Decision date
- 2022-01-24
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Approval for addition of a private label trade name.
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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 |