Trophy Skin

Basic Information

• Brand Name: Trophy Skin
• Primary DI: 00851561006020
• Version / Model: BlueMD
• Company Name: TROPHY SKIN, INC
• Labeler DUNS: 014294023
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 3
• Public Version Date: 2020-01-28
• Public Version Status: Update
• Public Device Record Key: 38f7a5a7-6a78-4c59-a52b-47f47d5d8fa1

Device Description

BlueMD, Blue Light Therapy Device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MXG	Lamp,Uvc,(For Treating Skin And Wounds)	General, Plastic Surgery	878.4630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59822	Skin photodynamic therapy/phototherapy lamp	A portable, mains electricity (AC-powered) lamp intended to emit low-level narrow-band (LLNB) red light (e.g., 600-650nm) and blue light (e.g., 415-440nm) either separately or simultaneously for photodynamic therapy (PDT) applications (with photosensitizing agent) to treat skin disorders such as actinic keratosis and non-melanoma skin cancer, and for phototherapy applications (through modification of skin metabolism) to treat skin complaints such as acne, rosacea and sun spots. It uses light-emitting diodes (LEDs) to produce a heatless light source which may be used for treatment at multiple anatomical sites. It is intended to be used by a healthcare professional in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851561006020	GS1

Customer Contacts

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