Submission Details
| 510(k) Number | K202932 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
ABT12 multi-purpose solution
May 2021
Decision
241d
Days
Class 2
Risk
About This 510(k) Submission
K202932 is an FDA 510(k) clearance for the ABT12 multi-purpose solution, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Bausch & Lomb, Incorporated (Rodchester, 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 review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
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