BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
FDA 510(k) clearance K132216 · decided 2013-09-09
Clearance details
- K-number
- K132216
- Device name
- BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION
- Applicant
- Bausch & Lomb, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2013-07-17
- Decision date
- 2013-09-09
- Days to decision
- 54 days
- Clearance type
- Special
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- 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
No recalls on record reference this clearance.
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 |