Cleared Special

MicroSTAAR Injector System Cartridges

K152357 · STAAR Surgical Company · Ophthalmic

Oct 2015

Decision

71d

Days

Class 1

Risk

About This 510(k) Submission

K152357 is an FDA 510(k) clearance for the MicroSTAAR Injector System Cartridges, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by STAAR Surgical Company (Monrovia, US). The FDA issued a Cleared decision on October 30, 2015, 71 days after receiving the submission on August 20, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number	K152357 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2015
Decision Date	October 30, 2015
Days to Decision	71 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF