Cleared Traditional

Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution

K180319 · Bausch and Lomb, Incorporated · Ophthalmic

Mar 2018

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K180319 is an FDA 510(k) clearance for the Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution, a Products, Contact Lens Care, Rigid Gas Permeable (Class II — Special Controls, product code MRC), submitted by Bausch and Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on March 27, 2018, 50 days after receiving the submission on February 5, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.

Submission Details

510(k) Number	K180319 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 05, 2018
Decision Date	March 27, 2018
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF