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 ID: 00850043007364
• NIH Device Record Key: 17da3726-0dd9-406e-905c-f68c8cfbdc5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Del Sol Blue Light Therapy System
• Version Model Number: Cordless (EU)
• Catalog Number: 70392-01
• 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

Customer Support Contacts

• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com
• Phone: 800-603-4996
• Email: regulatory@hydrafacial.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850043007364 [Package]; Contains: 00850043007371; Package: Box [1 Units]; In Commercial Distribution
GS1	00850043007371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061470

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-03

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

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