Submission Details
| 510(k) Number | K191949 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 22, 2019 |
| Decision Date | September 13, 2019 |
| Days to Decision | 53 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Abbreviated
UNFOLDER Vitan Inserter
Sep 2019
Decision
53d
Days
Class 1
Risk
About This 510(k) Submission
K191949 is an FDA 510(k) clearance for the UNFOLDER Vitan Inserter, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Johnson & Johnson Surgical Vision, Inc. (Santa Ana, US). The FDA issued a Cleared decision on September 13, 2019, 53 days after receiving the submission on July 22, 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
Johnson & Johnson Surgical Vision, Inc.
Santa Ana, CA · US
Silvia Jiang-Hughes
4 submissions
4 cleared
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