Submission Details
| 510(k) Number | K181627 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 20, 2018 |
| Decision Date | August 10, 2018 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
Aug 2018
Decision
51d
Days
Class 2
Risk
About This 510(k) Submission
K181627 is an FDA 510(k) clearance for the Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner, a Products, Contact Lens Care, Rigid Gas Permeable (Class II — Special Controls, product code MRC), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on August 10, 2018, 51 days after receiving the submission on June 20, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.
Device Classification
| Product Code | MRC — Products, Contact Lens Care, Rigid Gas Permeable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5918 |
Manufacturer
Similar Devices — MRC Products, Contact Lens Care, Rigid Gas Permeable
All 32
K251876 · Ophtecs Corporation
· Oct 2025
K200416 · Bausch & Lomb, Incorporated
· Sep 2020
K201069 · Dry Eye Innovations, LLC
· Jul 2020
K182984 · Omnivision AG
· Jul 2019
K181566 · Contamac, Ltd.
· Oct 2018
K180319 · Bausch and Lomb, Incorporated
· Mar 2018
More from Bausch & Lomb, Incorporated
View all
K242389
· MSS · Oct 2024
K230954
· LPL · Nov 2023
K220613
· LPL · Mar 2023
K222541
· LPN · Dec 2022
K211786
· LYX · Dec 2021