POLY Go

GUDID B3437000CA1

Hand Held LED Light Therapy Device. Uses LED to treat mild to moderate Acne. Contains rechargeable Battery

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: B3437000CA1
• NIH Device Record Key: 7f0074f6-72c6-4b36-9a2b-489780dc5db0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLY Go
• Version Model Number: POLY Go Clear
• Company DUNS: 002692106
• Company Name: Medtek Lighting Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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 Dimensions

• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter
• Area/Surface Area: 25 Square centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3437000CA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180900

FDA Product Code

• OLP: Over-The-Counter Powered Light Based Laser For Acne

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-18
• Device Publish Date: 2018-09-17

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