truSculpt flex— 510(k) K212866

Name: FDA 510(k) clearance K212866
Creator: U.S. Food and Drug Administration
Published: 2022-12-03

Substantially Equivalent

Johari Digital Healthcare Limited

FDA 510(k) clearance K212866 for truSculpt flex, Substantially Equivalent on 2022-12-03. Applicant: Johari Digital Healthcare Limited. Device class: 2.

Clearance details

Applicant: Johari Digital Healthcare Limited
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2021-09-08
Decision date: 2022-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jodhpur, IN

Download summary PDF View on FDA.gov ↗

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