Portable Slit Lamp— 510(k) K153545

Name: FDA 510(k) clearance K153545
Creator: U.S. Food and Drug Administration
Published: 2016-06-22

Substantially Equivalent

Shanghai Bolan Optical-Electric Co., Ltd.

FDA 510(k) clearance K153545 for Portable Slit Lamp, Substantially Equivalent on 2016-06-22. Applicant: Shanghai Bolan Optical-Electric Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Bolan Optical-Electric Co., Ltd.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2015-12-11
Decision date: 2016-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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