Luma Rx

GUDID 10074590540342

Intense Pulsed Light OTC Hair Removal Device

SPECTRUM BRANDS, INC.

Intense pulsed light skin surface treatment system

• Primary Device ID: 10074590540342
• NIH Device Record Key: 2a595aff-9c13-43d9-a124-3f951c875412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luma Rx
• Version Model Number: IPL6800USA
• Company DUNS: 001951946
• Company Name: SPECTRUM BRANDS, INC.
• 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

Customer Support Contacts

• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx
• Phone: 1-800-736-4648
• Email: xx@xx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00074590540345 [Primary]
GS1	10074590540342 [Package]; Contains: 00074590540345; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140631

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

On-Brand Devices [Luma Rx]

• 10074590543879: Consumable compontent for IPL6800 device
• 10074590543862: Consumable component for IPL6800 device
• 10074590543138: Intense Pulsed Light OTC hair removal device
• 10074590542377: Consumable component for IPL6800 devices
• 10074590540342: Intense Pulsed Light OTC Hair Removal Device