EndyMed Pure 2.0 system 110V PURE logo

FDA UDI

Class II (US FDA UDI)

by Endymed Medical Ltd

Identity

Trade Name: EndyMed Pure 2.0 system 110V PURE logo FDA UDI
Generic Name: Multi-modality skin/body contouring system FDA UDI
Device Name: The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure. FDA UDI
Model / Reference: Pure 2.0 system 110V PURE logo FDA UDI
Description: The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure. FDA UDI

Identifiers

Catalog Number: ND_PRD00413-00 FDA UDI
Primary DI / UDI-DI: 07290016814279 FDA UDI
510(k) Number: K120513 FDA UDI
FDA Product Code: GEI FDA UDI
OUH 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

Yes

FDA UDI

Category: Multi-modality skin/body contouring system

EndyMed Pure 2.0 system 110V PURE logo 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 e3cdd7eb-f772-494f-a6fd-20aaa09bf624 36 fields · synced Jun 8, 2026