Del Sol Blue Light Therapy System 70392-01

GUDID 00850043007364

Del Sol Blue Cordless LED Light for EU/CE only

EDGE SYSTEMS LLC

Skin photodynamic therapy/phototherapy lamp
Primary Device ID00850043007364
NIH Device Record Key17da3726-0dd9-406e-905c-f68c8cfbdc5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDel Sol Blue Light Therapy System
Version Model NumberCordless (EU)
Catalog Number70392-01
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
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com
Phone800-603-4996
Emailregulatory@hydrafacial.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850043007364 [Package]
Contains: 00850043007371
Package: Box [1 Units]
In Commercial Distribution
GS100850043007371 [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 Date2017-07-03

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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