truSculpt— 510(k) K172004

Substantially Equivalent

Cutera, Inc.

FDA 510(k) clearance K172004 for truSculpt, Substantially Equivalent on 2017-08-02. 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: 2017-07-03
Decision date: 2017-08-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Brisbane, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

K253480 — Capenergy C Equipments RF C200 and C400 Drakarian2026-07-10
K260647 — SPECCHIO2026-04-02
K253261 — Apollo Quattro (APQ-10M)2026-03-13
K252888 — NeoSculpt Plus2026-03-09
K250734 — OptiLUV Device2025-09-10

More clearances from Cutera, Inc.

K251149 — AviClear Laser System2025-07-11
K233237 — xeo+ Family2023-12-15
K230660 — AviClear Laser System2023-06-06
K223110 — truSculpt iD2022-11-03
K221407 — truSculpt iD2022-07-13

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