Poly Spot

Basic Information

• Brand Name: Poly Spot
• Primary DI: B3437000C21
• Version / Model: 7000C2
• Company Name: Medtek Lighting Corporation
• Labeler DUNS: 002692106
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-01
• Public Version: 3
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: ea76ccd1-bcf6-48de-9214-92d6c7d16caa

Device Description

Handheld LED Light Therapy Device. Treatment heads, available in Blue (415nm) or Red (633nm), help to mitigate a variety of skin conditions. There are 8 LEDs to provide a treatment area of 4 sq. cm. Batery powered with a charger

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
PWC	General Wellness Product	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
62202	Blue/red/infrared phototherapy lamp	A portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B3437000C21	HIBCC

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	4	Square centimeter