EndyMed Pure 2.0 system 220V PURE logo ND_PRD00208

GUDID 07290016814231

The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure.

ENDYMED MEDICAL LTD

Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system
Primary Device ID07290016814231
NIH Device Record Keyd45c9695-4d77-42bc-aa3c-590c2bc25abc
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndyMed Pure 2.0 system 220V PURE logo
Version Model NumberPure 2.0 system 220V PURE logo
Catalog NumberND_PRD00208
Company DUNS531958689
Company NameENDYMED MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com
Phone1-855-363-9633
Emailservice@endymed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016814231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OUHSkin Resurfacing Rf Applicator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-03-21
Device Publish Date2019-03-03

Devices Manufactured by ENDYMED MEDICAL LTD

17290014660127 - NEWA+, Kit, US, PINK2023-11-28 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin
17290016814351 - EndyGel 2023-07-12 EndyGel is an Electroconductive gel media used with external electrode to reduce the impedance (resistance to alternating curren
07290016814361 - PURE Laser, System2023-06-27 The PURE Laser system is a non-invasive laser based system used for Hair Removal
07290016814378 - PURE Laser, EPL810 HP2023-06-27 The handpiece of the PURE Laser system which delivers pulsed laser light (wavelength 810nm) from the diode array to the treatme
17290014660110 - NEWA PLUS Kit2022-01-17 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin
07290014660083 - NEWA Kit2021-10-01 The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles
17290014660028 - NEWA PLUS Kit2021-05-06 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin
07290014660014 - NEWA PLUS Kit2021-04-28 The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrin

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