WORLD AESTHETIX BROAD PULSED LIGHT

GUDID 00850062978003

The World Aesthetix Broad Pulsed Light device is indicated for use in surgical, aesthetic applications in permanent hair reduction, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

WORLD AESTHETIX LLC

Intense pulsed light skin surface treatment system

• Primary Device ID: 00850062978003
• NIH Device Record Key: 95d34491-fd3f-48cc-acb3-884edd946f11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WORLD AESTHETIX BROAD PULSED LIGHT
• Version Model Number: WAX161286
• Company DUNS: 931002047
• Company Name: WORLD AESTHETIX 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: 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	00850062978003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161286

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-03
• Device Publish Date: 2024-06-25