EndyMed Pure Shaper Handpiece

FDA UDI

Class II (US FDA UDI)

by Endymed Medical Ltd

Identity

Trade Name: EndyMed Pure Shaper Handpiece FDA UDI
Generic Name: Multi-modality skin/body contouring system FDA UDI
Device Name: The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides. FDA UDI
Model / Reference: Shaper Handpiece FDA UDI
Description: The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides. FDA UDI

Identifiers

Catalog Number: ND_PRD00097 FDA UDI
Primary DI / UDI-DI: 07290016814040 FDA UDI
510(k) Number: K120513 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Multi-modality skin/body contouring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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

FDA UDI

Category: Multi-modality skin/body contouring system

EndyMed Pure Shaper Handpiece by Endymed Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K120513 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Endymed Medical Ltd

Sources (1)

FDA UDI 9930440a-04c1-4965-b3a0-ad9391f8a528 36 fields · synced Jun 1, 2026