Submission Details
| 510(k) Number | K173480 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 13, 2017 |
| Decision Date | December 11, 2017 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
Crystalsert Lens Delivery System
Dec 2017
Decision
28d
Days
Class 1
Risk
About This 510(k) Submission
K173480 is an FDA 510(k) clearance for the Crystalsert Lens Delivery System, 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 December 11, 2017, 28 days after receiving the submission on November 13, 2017. 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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