UVBioTerk 60B

GUDID B343B60

Phototherapy Unit. UVB Narrowband. Single upright unit with six 72" lamps. Mounts to wall or stand.

Medtek Lighting Corporation

Ultraviolet phototherapy unit, professional Ultraviolet phototherapy unit, professional

• Primary Device ID: B343B60
• NIH Device Record Key: c40bfeeb-aee5-4909-a981-ea644be8aa70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UVBioTerk
• Version Model Number: 60B
• Catalog Number: 60B
• Company DUNS: 002692106
• Company Name: Medtek Lighting Corporation
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Weight: 160 Pound
• Area/Surface Area: 1311 Square inch
• Weight: 160 Pound
• Area/Surface Area: 1311 Square inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B343B60 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K134009

FDA Product Code

• FTC: Light, Ultraviolet, Dermatological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-21
• Device Publish Date: 2017-02-09

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