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EndyMed PRO 85W System Body 2200V

FDA UDI

Class II (US FDA UDI)

by Endymed Medical Ltd

Identity

Trade Name
EndyMed PRO 85W System Body 2200V FDA UDI
Generic Name
Multi-modality skin/body contouring system FDA UDI
Device Name
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides FDA UDI
Model / Reference
PRO 85W System Body 2200V FDA UDI
Description
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides FDA UDI

Identifiers

Catalog Number
ND_PRD00009_F_B FDA UDI
Primary DI / UDI-DI
07290016814194 FDA UDI
510(k) Number
K083461 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

EndyMed PRO 85W System Body 2200V by Endymed Medical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K083461 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endymed Medical Ltd

Sources (1)

  • FDA UDI b44881bd-16e3-414f-8c5a-c17c7fb8b549 37 fields · synced Jun 1, 2026