BodySculp— 510(k) K212331

Substantially Equivalent

Rohrer Aesthetics, LLC

FDA 510(k) clearance K212331 for BodySculp, Substantially Equivalent on 2021-11-09. Applicant: Rohrer Aesthetics, LLC. Device class: 2.

Clearance details

Applicant: Rohrer Aesthetics, LLC
Product code: Code PKT
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2021-07-27
Decision date: 2021-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, AL, 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.