KBL 8000 alpha hybridSun

GUDID 04260489020142

This device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning of the human skin of an adult person.

KBL GmbH

Ultraviolet tanning device

• Primary Device ID: 04260489020142
• NIH Device Record Key: c03907f7-4af1-471d-87ef-72c971e75aa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KBL 8000 alpha hybridSun
• Version Model Number: KBL 7908 - 50h/4g 1616 cpi us (T)
• Company DUNS: 341936227
• Company Name: KBL GmbH
• Device Count: 1
• DM Exempt: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260489020142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191881

FDA Product Code

• LEJ: Booth, Sun Tan

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: 2020-06-11
• Device Publish Date: 2020-06-03

Devices Manufactured by KBL GmbH

• 04260489020418 - KBL K11 Air (Loft): 2024-05-23 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
• 04260489020401 - KBL K9S vitaSun: 2024-03-15 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
• 04260489020357 - KBL K5 pureSun: 2023-06-19 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
• 04260489020364 - KBL K5 extraSun: 2023-06-19 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
• 04260489020371 - KBL K5 hybridSun: 2023-06-19 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
• 04260489020388 - KBL K9S extraSun: 2023-06-19 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
• 04260489020395 - KBL K9S hybridSun: 2023-06-19 The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended f
• 04260489020227 - KBL Tower Space 3000 hybridSun: 2021-08-25 This device is an over-the-counter device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tann