K202932 is an FDA 510(k) clearance for the ABT12 multi-purpose solution. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).
Submitted by Bausch & Lomb, Incorporated (Rochester, US). The FDA issued a Cleared decision on May 28, 2021, 241 days after receiving the submission on September 29, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K202932 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2020 |
| Decision Date | May 28, 2021 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5928 |