7LS FA7-1450J

GUDID 00031262096265

ReNew Light Therapy

FKA DISTRIBUTING CO., LLC

Red/blue light phototherapy unit

• Primary Device ID: 00031262096265
• NIH Device Record Key: 99b1a3b2-47db-4ba5-b6ae-e6b7ef51d5a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 7LS
• Version Model Number: FA7-1450J
• Catalog Number: FA7-1450J
• Company DUNS: 183280973
• Company Name: FKA DISTRIBUTING CO., LLC
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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: 248-863-3176
• Email: cservice@7LSbeauty.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00031262096265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162098

FDA Product Code

• OHS: Light Based Over The Counter Wrinkle Reduction

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: 2020-03-09
• Device Publish Date: 2020-02-29

On-Brand Devices [7LS]

• 00031262096531: ReSculpt Micro-Current & Light Therapy
• 00031262096265: ReNew Light Therapy