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

• 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