Primary Device ID | 00850043007340 |
NIH Device Record Key | 902fff92-3ccf-4592-80b6-8f191efb2240 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Del Sol Red Light Therapy System |
Version Model Number | Cordless (EU) |
Catalog Number | 70393-01 |
Company DUNS | 364134791 |
Company Name | EDGE SYSTEMS LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com | |
Phone | 800-603-4996 |
regulatory@hydrafacial.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850043007340 [Primary] |
GS1 | 00850043007357 [Package] Package: Box [1 Units] In Commercial Distribution |
ILY | Lamp, Infrared, Therapeutic Heating |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2017-07-03 |
00850043007340 | Del Sol Red Cordless LED Light for EU/CE only |
00850043007043 | Red LED Handpiece with Power Supply |
00850043007029 | Red LED Handpiece, 12V |
00850043007005 | Red Cordless LED - US |