Del Sol Red Light Therapy System

Basic Information

• Brand Name: Del Sol Red Light Therapy System
• Primary DI: 00850043007005
• Version / Model: Cordless (US)
• Catalog Number: 70393
• Company Name: Hydrafacial LLC
• Labeler DUNS: 364134791
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-16
• Public Version: 4
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: f09d1d48-802d-45c8-a33b-620e7b6dcda7

Device Description

Red Cordless LED - US

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47705	Cosmetic red-light phototherapy system, professional	An assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in a professional setting. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by healthcare personnel typically for patient body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850043007005	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]