Pearl Fractional

GUDID 00816722022844

Pearl Fractional Laser Handpiece for xeo+/xeo+ SA

CUTERA, INC.

Dermatological laser beam guiding handpiece

• Primary Device ID: 00816722022844
• NIH Device Record Key: 194d8261-b7bc-4b0e-a5b9-7f4cae13050f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pearl Fractional
• Version Model Number: Pearl Fractional
• Company DUNS: 041071643
• Company Name: CUTERA, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816722022844 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080530

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: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [Pearl Fractional]

• 00816722022158: Pearl Fractional Laser Handpiece
• 00816722022844: Pearl Fractional Laser Handpiece for xeo+/xeo+ SA