truSculpt 40 HF

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 7001920

by Cutera, Inc.

Identity

Trade Name: truSculpt 40 HF EUDAMED
truSculpt iD Hands Free 40 FDA UDI
Generic Name: Radio-frequency skin contouring system applicator, monopolar FDA UDI
Device Name: truSculpt 40 HF EUDAMED
truSculpt iD Hands Free 40 Handpiece FDA UDI
Model / Reference: 7001920 EUDAMED
truSculpt iD Hands Free 40 FDA UDI
Description: truSculpt iD Hands Free 40 Handpiece FDA UDI

Identifiers

Primary DI / UDI-DI: 00816722022462 EUDAMEDFDA UDI
Basic UDI-DI: B-00816722022462 EUDAMED
FDA Product Code: GEI FDA UDI
PBX FDA UDI
EMDN Code: Z12010999 ELECTROSURGERY INSTRUMENTS - OTHER EUDAMED
GMDN Term: Radio-frequency skin contouring system applicator, monopolar FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Market of Registration: France EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

The truSculpt 40 HF is a high-intensity focused ultrasound (HIFU) device for non-invasive body contouring, classified under nomenclature code Z12010999. It delivers focused ultrasound energy to selectively heat and contract subcutaneous fat tissues, aiding in the reduction of localized fat deposits without surgical intervention.

This device is intended for single-use applications in clinical or aesthetic settings and is not sterile or implantable. Supplied as a non-reusable system, it requires proper handling and disposal per manufacturer guidelines. Authorized under FDA 510(k) and MDD compliance, it is distributed by MDSS GmbH under UDI B-00816722022462. Storage and usage must adhere to regulatory and safety protocols to ensure efficacy and patient safety.

Frequently asked questions

What is the truSculpt 40 HF device used for?

The truSculpt 40 HF is a high-intensity focused ultrasound (HIFU) device designed for non-invasive body contouring. It delivers focused ultrasound energy to selectively heat and contract subcutaneous fat tissues, helping to reduce localized fat deposits without surgical intervention.

Is the truSculpt 40 HF reusable or sterile?

The truSculpt 40 HF is not sterile and is intended for single-use applications only. It is supplied as a non-reusable system that requires proper handling and disposal according to manufacturer guidelines.

What are the regulatory authorizations for the truSculpt 40 HF?

The truSculpt 40 HF is authorized under FDA 510(k) and MDD compliance. It is classified under nomenclature code Z12010999 and distributed by MDSS GmbH with UDI B-00816722022462.

How should the truSculpt 40 HF be stored?

Storage and usage of the truSculpt 40 HF must adhere to regulatory and safety protocols to ensure efficacy and patient safety. Specific storage conditions should follow manufacturer guidelines.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDD

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K133739	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K162512	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K172004	Class IIb	Active
FDA 510(k)	United States	FDA_510K	K122389	Class IIb	Active
EUDAMED	European Union	CE/MDD	B-00816722022462	Class IIb	Active

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Manufacturer

Manufacturer: Cutera, Inc.
EUDAMED SRN: US-MF-000010456
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (3)

EUDAMED bbd2982e-93be-4beb-a3a4-98ad9ca16e37 61 fields · synced Sep 18, 2026
FDA UDI a33721fe-5ec9-4df7-b041-261ef6e5e4f4 33 fields · synced May 30, 2026
FDA 510(k) K133739 1 fields · synced May 18, 2026