K181627 is an FDA 510(k) clearance for the Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner. This device is classified as a Products, Contact Lens Care, Rigid Gas Permeable (Class II - Special Controls, product code MRC).
Submitted by Bausch & Lomb, Incorporated (Rochester, 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 FDA review panel. Regulated under 21 CFR 886.5918.
| 510(k) Number | K181627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | MRC — Products, Contact Lens Care, Rigid Gas Permeable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5918 |