PURE Laser, EPL810 HP ND_PRD00459-00

GUDID 07290016814378

The handpiece of the PURE Laser system which delivers pulsed laser light (wavelength 810nm) from the diode array to the treatment area.

ENDYMED MEDICAL LTD

Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece Dermatological laser beam producing handpiece
Primary Device ID07290016814378
NIH Device Record Key2e5ed0fa-6d38-4d07-9b5b-0c298e261f47
Commercial Distribution StatusIn Commercial Distribution
Brand NamePURE Laser, EPL810 HP
Version Model NumberEPL810 HP
Catalog NumberND_PRD00459-00
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
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com
Phone1-855-363-9633
Emailsupport@endymed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016814378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-27
Device Publish Date2023-06-19

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