Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care— 510(k) K161458

Name: FDA 510(k) clearance K161458
Creator: U.S. Food and Drug Administration
Published: 2016-10-03

Substantially Equivalent

Indiba USA, Inc.

FDA 510(k) clearance K161458 for Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care, Substantially Equivalent on 2016-10-03. Applicant: Indiba USA, Inc.. Device class: 2.

Clearance details

Applicant: Indiba USA, Inc.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2016-05-26
Decision date: 2016-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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