Del Sol Blue Light Therapy System 70146

GUDID 00850043007036

Blue LED Handpiece, 5V

EDGE SYSTEMS LLC

Skin photodynamic therapy/phototherapy lamp
Primary Device ID00850043007036
NIH Device Record Key809ed85b-44f3-4b47-8e51-61cd6d7f23ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameDel Sol Blue Light Therapy System
Version Model Number5V
Catalog Number70146
Company DUNS364134791
Company NameEDGE SYSTEMS LLC
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com
Phone800-603-4996
Emailcontact@edgeforlife.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850043007036 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-16

On-Brand Devices [Del Sol Blue Light Therapy System]

00850043007364Del Sol Blue Cordless LED Light for EU/CE only
00850043007050Blue LED Handpiece with Power Supply
00850043007036Blue LED Handpiece, 5V
00850043007012Blue Cordless LED - US

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