REMY Medical Therapy Laser System— 510(k) K190034

Name: FDA 510(k) clearance K190034
Creator: U.S. Food and Drug Administration
Published: 2019-05-15

Substantially Equivalent

Footdocprenur, LLC

FDA 510(k) clearance K190034 for REMY Medical Therapy Laser System, Substantially Equivalent on 2019-05-15. Applicant: Footdocprenur, LLC. Device class: 2.

Clearance details

Applicant: Footdocprenur, LLC
Product code: Code PDZ
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2019-01-07
Decision date: 2019-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cherry Hill, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.