Poly Go

GUDID B3437000C1

Handheld LED Light Therapy Device. Treatment heads, available in Red (633nm), Blue (415nm) and Infrared (850nm), help to mitigate a variety of skin co

Medtek Lighting Corporation

Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp

• Primary Device ID: B3437000C1
• NIH Device Record Key: ccb3242b-c72d-4d9a-87ad-756e706c5897
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Poly Go
• Version Model Number: 7000C
• Company DUNS: 002692106
• Company Name: Medtek Lighting Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3437000C1 [Primary]

FDA Product Code

• PWC: General Wellness Product

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-09-01

On-Brand Devices [Poly Go]

• B3437000CA1: Hand Held LED Light Therapy Device. Uses LED to treat mild to moderate Acne. Contains rechargeab
• B3437000C1: Handheld LED Light Therapy Device. Treatment heads, available in Red (633nm), Blue (415nm) and I