Submission Details
| 510(k) Number | K212039 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 30, 2021 |
| Decision Date | August 23, 2021 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
CLAREON MONARCH IV IOL Delivery System
Aug 2021
Decision
54d
Days
Class 1
Risk
About This 510(k) Submission
K212039 is an FDA 510(k) clearance for the CLAREON MONARCH IV IOL Delivery System, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Alcon Laboratories, Inc. (Fort Worth,, US). The FDA issued a Cleared decision on August 23, 2021, 54 days after receiving the submission on June 30, 2021. 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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