Poly Pro

GUDID B3437000A2

LED Light Therapy Device. Uses 1820 LEDs at 633nm to treat facial wrinkles. Available for use in Salons, Spas, Med Spas, Dermatology.

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: B3437000A2
• NIH Device Record Key: d4d78814-acbc-4d09-a784-bab4c4d8990c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Poly Pro
• Version Model Number: Poly Pro Rejuv
• Company DUNS: 002692106
• Company Name: Medtek Lighting Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Customer Support Contacts

• Phone: 518-747-3310
• Email: info@uvbiotek.com
• Phone: 518-747-3310
• Email: info@uvbiotek.com
• Phone: 518-747-3310
• Email: info@uvbiotek.com
• Phone: 518-747-3310
• Email: info@uvbiotek.com
• Phone: 518-747-3310
• Email: info@uvbiotek.com
• Phone: 518-747-3310
• Email: info@uvbiotek.com
• Phone: 518-747-3310
• Email: info@uvbiotek.com
• Phone: 518-747-3310
• Email: info@uvbiotek.com
• Phone: 518-747-3310
• Email: info@uvbiotek.com
• Phone: 518-747-3310
• Email: info@uvbiotek.com
• Phone: 518-747-3310
• Email: info@uvbiotek.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3437000A2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180875

FDA Product Code

• OHS: Light Based Over The Counter Wrinkle Reduction

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: 2018-10-22
• Device Publish Date: 2018-09-19

On-Brand Devices [Poly Pro]

• B3437000A3: LED Light Therapy. Uses 1820 LED. Purpose is to relieve minor joint or muscle pain using Infrare
• B3437000A2: LED Light Therapy Device. Uses 1820 LEDs at 633nm to treat facial wrinkles. Available for use in