Submission Details
| 510(k) Number | K222541 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 22, 2022 |
| Decision Date | December 06, 2022 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
Dec 2022
Decision
106d
Days
Class 2
Risk
About This 510(k) Submission
K222541 is an FDA 510(k) clearance for the Bausch + Lomb Preservative Free Lubricating and Rewetting Drops, 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 December 6, 2022, 106 days after receiving the submission on August 22, 2022. 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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