Del Sol Red Light Therapy System 70393-01

GUDID 00850043007340

Del Sol Red Cordless LED Light for EU/CE only

EDGE SYSTEMS LLC

Cosmetic red-light phototherapy system, professional
Primary Device ID00850043007340
NIH Device Record Key902fff92-3ccf-4592-80b6-8f191efb2240
Commercial Distribution StatusIn Commercial Distribution
Brand NameDel Sol Red Light Therapy System
Version Model NumberCordless (EU)
Catalog Number70393-01
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
GS100850043007340 [Primary]
GS100850043007357 [Package]
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-07-03

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

00850043007340Del Sol Red Cordless LED Light for EU/CE only
00850043007043Red LED Handpiece with Power Supply
00850043007029Red LED Handpiece, 12V
00850043007005Red Cordless LED - US

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