Silk'n MODEL H5003 device— 510(k) K180279

Name: FDA 510(k) clearance K180279
Creator: U.S. Food and Drug Administration
Published: 2018-05-09

Substantially Equivalent

Home Skinovations , Ltd.

FDA 510(k) clearance K180279 for Silk'n MODEL H5003 device, Substantially Equivalent on 2018-05-09. Applicant: Home Skinovations , Ltd.. Device class: 2.

Clearance details

Applicant: Home Skinovations , Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2018-01-31
Decision date: 2018-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

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