KBL K9S hybridSun

GUDID 04260489020395

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

KBL GmbH

Ultraviolet tanning device

• Primary Device ID: 04260489020395
• NIH Device Record Key: 17fd304e-690c-47b4-a3bf-a76a28c9af58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KBL K9S hybridSun
• Version Model Number: K9S-h-52-9s-2s UP cpi 05
• 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	04260489020395 [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: 2023-06-19
• Device Publish Date: 2023-06-09

Devices Manufactured by KBL GmbH

• 04260489020425 - R11 Air: 2025-07-03 Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain i
• 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: 2023-06-19The device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning the human skin of an adult person.
• 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