TRUSCULPT— 510(k) K122389

Substantially Equivalent

Cutera, Inc.

FDA 510(k) clearance K122389 for TRUSCULPT, Substantially Equivalent on 2012-11-02. 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: 2012-08-07
Decision date: 2012-11-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Brisbane, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

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K252888 — NeoSculpt Plus2026-03-09
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More clearances from Cutera, Inc.

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K221407 — truSculpt iD2022-07-13

Recalls naming K122389

K-number listed on FDA's recall record

Z-0427-2014 — Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.Class II·Terminated·Cutera, Inc.·20131016

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122389.

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