Submission Details
| 510(k) Number | K192005 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 2019 |
| Decision Date | October 04, 2019 |
| Days to Decision | 67 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
Bausch + Lomb PreVue Inserter for enVista Preloaded
Oct 2019
Decision
67d
Days
Class 1
Risk
About This 510(k) Submission
K192005 is an FDA 510(k) clearance for the Bausch + Lomb PreVue Inserter for enVista Preloaded, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Bausch & Lomb, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 4, 2019, 67 days after receiving the submission on July 29, 2019. 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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