Submission Details
| 510(k) Number | K242389 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 2024 |
| Decision Date | October 10, 2024 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
EyeGility? Inserter for Preloaded enVista IOLs
Oct 2024
Decision
59d
Days
Class 1
Risk
About This 510(k) Submission
K242389 is an FDA 510(k) clearance for the EyeGility? Inserter for Preloaded enVista IOLs, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on October 10, 2024, 59 days after receiving the submission on August 12, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.
Device Classification
| Product Code | MSS — Folders And Injectors, Intraocular Lens (iol) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.4300 |
Manufacturer
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