truSculpt RF Device; truSculpt; truSculpt 3D— 510(k) K180709

Name: FDA 510(k) clearance K180709
Creator: U.S. Food and Drug Administration
Published: 2018-06-06

Substantially Equivalent

Cutera, Inc.

FDA 510(k) clearance K180709 for truSculpt RF Device; truSculpt; truSculpt 3D, Substantially Equivalent on 2018-06-06. Applicant: Cutera, Inc.. Device class: 2.

Clearance details

Applicant: Cutera, Inc.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2018-03-19
Decision date: 2018-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brisbane, CA, US

Download summary PDF View on FDA.gov ↗

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K252888 — NeoSculpt Plus2026-03-09
K250734 — OptiLUV Device2025-09-10

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K221407 — truSculpt iD2022-07-13

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