Cleared Traditional

SLM-1ER, SLM-2ER, SLM-3ER

K171877 · Chongqing Kanghua Ruiming S&T Co., Ltd. · Ophthalmic

Dec 2017

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K171877 is an FDA 510(k) clearance for the SLM-1ER, SLM-2ER, SLM-3ER, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Chongqing Kanghua Ruiming S&T Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on December 21, 2017, 181 days after receiving the submission on June 23, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K171877 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2017
Decision Date	December 21, 2017
Days to Decision	181 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF