Poly Spot

GUDID B3437000C21

Handheld LED Light Therapy Device. Treatment heads, available in Blue (415nm) or Red (633nm), help to mitigate a variety of skin conditions. There are

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: B3437000C21
• NIH Device Record Key: ea76ccd1-bcf6-48de-9214-92d6c7d16caa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Poly Spot
• Version Model Number: 7000C2
• 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 Dimensions

• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter
• Area/Surface Area: 4 Square centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3437000C21 [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

Devices Manufactured by Medtek Lighting Corporation

• B3437000A1 - POLY: 2020-03-09 LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm) and/or Infrared (850nm). The wavelengths are ava
• B343B100 - UVBioTek: 2018-12-21 Phototherapy Unit. UVB Narrowband. Single upright panel with 10 lamps. Mounts to wall or to stand.
• B343B1600 - UVBioTek: 2018-12-21 Phototherapy Unit. UVB Narrowband. 4 Connected Panels, attached to a wall, wrap around patient. 16 lamps, each 72" in height.
• B343B20 - UVBioTek: 2018-12-21 Phototherapy Unit. UVB Narrow Band. Single upright Panel with Two 72" Lamps. Mounts to Wall.
• B343B2400 - UVBioTek: 2018-12-21 Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 24 lamps, each 72" in height. Cl
• B343B3200 - UVBioTek: 2018-12-21 Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 32 Lamps, each 72" in height. Cl
• B343B40 - UVBioTek: 2018-12-21 Phototherapy Unit. UVB Narrowband. Single upright panel with Four 72" lamps. Mounts to wall or stand.
• B343B4000 - UVBioTek: 2018-12-21 Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 40 lamps, each 72" in height. Cl