Submission Details
| 510(k) Number | K173089 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2017 |
| Decision Date | November 27, 2017 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
Nov 2017
Decision
59d
Days
Class 2
Risk
About This 510(k) Submission
K173089 is an FDA 510(k) clearance for the Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions, 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 November 27, 2017, 59 days after receiving the submission on September 29, 2017. 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
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