Dermalux 1000021

GUDID 50607624600118

4-Pod LED phototherapy device.

AESTHETIC TECHNOLOGY LTD

Blue/red/infrared phototherapy lamp

• Primary Device ID: 50607624600118
• NIH Device Record Key: b218ad29-7124-4064-84c8-379fd5973fe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermalux
• Version Model Number: Tri-Wave MD MKII
• Catalog Number: 1000021
• Company DUNS: 218753736
• Company Name: AESTHETIC TECHNOLOGY LTD
• 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

• Length: 679.7 Millimeter
• Height: 1087.4 Millimeter
• Width: 517.7 Millimeter
• Weight: 55 Kilogram
• Length: 679.7 Millimeter
• Height: 1087.4 Millimeter
• Width: 517.7 Millimeter
• Weight: 55 Kilogram
• Length: 679.7 Millimeter
• Height: 1087.4 Millimeter
• Width: 517.7 Millimeter
• Weight: 55 Kilogram
• Length: 679.7 Millimeter
• Height: 1087.4 Millimeter
• Width: 517.7 Millimeter
• Weight: 55 Kilogram
• Length: 679.7 Millimeter
• Height: 1087.4 Millimeter
• Width: 517.7 Millimeter
• Weight: 55 Kilogram
• Length: 679.7 Millimeter
• Height: 1087.4 Millimeter
• Width: 517.7 Millimeter
• Weight: 55 Kilogram
• Length: 679.7 Millimeter
• Height: 1087.4 Millimeter
• Width: 517.7 Millimeter
• Weight: 55 Kilogram
• Length: 679.7 Millimeter
• Height: 1087.4 Millimeter
• Width: 517.7 Millimeter
• Weight: 55 Kilogram
• Length: 679.7 Millimeter
• Height: 1087.4 Millimeter
• Width: 517.7 Millimeter
• Weight: 55 Kilogram
• Length: 679.7 Millimeter
• Height: 1087.4 Millimeter
• Width: 517.7 Millimeter
• Weight: 55 Kilogram
• Length: 679.7 Millimeter
• Height: 1087.4 Millimeter
• Width: 517.7 Millimeter
• Weight: 55 Kilogram

Device Identifiers

Device Issuing Agency	Device ID
GS1	50607624600118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240222

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2025-09-10
• Device Publish Date: 2025-09-02

On-Brand Devices [Dermalux]

• 50607624600804: The Dermalux® Flex MD is a Medical Device for use on a treatment bed/surface. The device emits
• 50607624600286: The Dermalux® Flex MD is a Medical Device for use on a treatment bed/surface. The device emits
• 50607624600118: 4-Pod LED phototherapy device.