Cleared Special

K151102 - Bausch + Lomb Injector System
(FDA 510(k) Clearance)

K151102 · Bausch & Lomb, Inc. · Ophthalmic

May 2015

Decision

28d

Days

Class 1

Risk

K151102 is an FDA 510(k) clearance for the Bausch + Lomb Injector System, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by Bausch & Lomb, Inc. (Irvine, US). The FDA issued a Cleared decision on May 22, 2015, 28 days after receiving the submission on April 24, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number	K151102 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2015
Decision Date	May 22, 2015
Days to Decision	28 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF