R11 Air

GUDID 04260489020425

Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain indications.

KBL GmbH

Red/infrared light phototherapy unit

• Primary Device ID: 04260489020425
• NIH Device Record Key: a18e6928-123f-494d-98f4-8ba703b13989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R11 Air
• Version Model Number: R11-s-2848r1-1188i1 UP 12
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260489020425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202955

FDA Product Code

• OLI: Fat Reducing Low Level Laser

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: 2025-07-03
• Device Publish Date: 2025-06-25

Devices Manufactured by KBL GmbH

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