Cleared Traditional

Sunkingdom Slit Lamp

K182306 · Chongqing Sunkingdom Medical Instrument Co., Ltd. · Ophthalmic

Nov 2018

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K182306 is an FDA 510(k) clearance for the Sunkingdom Slit Lamp, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Chongqing Sunkingdom Medical Instrument Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on November 22, 2018, 90 days after receiving the submission on August 24, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K182306 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2018
Decision Date	November 22, 2018
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF