BAUSCH + LOMB NESOFILCON A CONTACT LENS
FDA 510(k) clearance K113703 · decided 2012-06-05
Clearance details
- K-number
- K113703
- Device name
- BAUSCH + LOMB NESOFILCON A CONTACT LENS
- Applicant
- Bausch & Lomb, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2011-12-16
- Decision date
- 2012-06-05
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 720 recall (Z-0206-2016) | Bausch & Lomb Inc Irb | 2015-11-04 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P080021) | Bausch & Lomb, Incorporated | 2009-02-02 |