Cleared Special

MicroSTAAR Injector System Cartridges

K172375 · STAAR Surgical Company · Ophthalmic

Sep 2017

Decision

30d

Days

Class 1

Risk

About This 510(k) Submission

K172375 is an FDA 510(k) clearance for the MicroSTAAR Injector System Cartridges, a Folders And Injectors, Intraocular Lens (iol) (Class I — General Controls, product code MSS), submitted by STAAR Surgical Company (Monrovia, US). The FDA issued a Cleared decision on September 6, 2017, 30 days after receiving the submission on August 7, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number	K172375 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 07, 2017
Decision Date	September 06, 2017
Days to Decision	30 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF