Bausch + Lomb Ultra (samfilcon A) Contact Lenses
FDA premarket approval P170035 · decided 2018-04-30
Approval details
- PMA number
- P170035
- Trade name
- Bausch + Lomb Ultra (samfilcon A) Contact Lenses
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch and Lomb, Inc.,
- Date received
- 2017-11-01
- Decision date
- 2018-04-30
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Approval for the Bausch + Lomb Ultra (samfilcon A) Contact Lenses. These devices are indicated for:Single Vision Spherical (SVS) Vision CorrectionThe BAUSCH + LOMB ULTRA (samfilcon A) Contact Lens is indicated for extended wear for up to 7 days between removals for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-dis
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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 |