Submission Details
| 510(k) Number | K113852 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 29, 2011 |
| Decision Date | September 28, 2012 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
BAUSCH & LOMB IOL INJECTOR
Sep 2012
Decision
274d
Days
Class 1
Risk
About This 510(k) Submission
K113852 is an FDA 510(k) clearance for the BAUSCH & LOMB IOL INJECTOR, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Bausch & Lomb, Inc. (Alusi Vuejo, US). The FDA issued a Cleared decision on September 28, 2012, 274 days after receiving the submission on December 29, 2011. 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
Similar Devices — MSS Folders And Injectors, Intraocular Lens (iol)
All 61
K252540 · Medicel AG
· Sep 2025
K242389 · Bausch & Lomb, Incorporated
· Oct 2024
K231106 · Medicel AG
· Sep 2023
K231838 · Rxsight, Inc.
· Aug 2023
K231466 · Rxsight, Inc.
· Jun 2023
K212039 · Alcon Laboratories, Inc.
· Aug 2021
More from Bausch & Lomb, Inc.
View all
K192005
· MSS · Oct 2019
K173480
· MSS · Dec 2017
K151102
· MSS · May 2015
K131208
· LPL · Sep 2013
K122575
· LPL · Dec 2012