Prowave

GUDID 00816722022820

Prowave IPL Handpiece for xeo+/xeo+ SA

CUTERA, INC.

Light-energy skin surface treatment system applicator

• Primary Device ID: 00816722022820
• NIH Device Record Key: 330af7b9-0ea6-41a5-aef8-1b41bd200625
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prowave
• Version Model Number: Prowave
• 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	00816722022820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050047

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

Devices Manufactured by CUTERA, INC.

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• 00816722021809 - xeo+: 2022-12-08 xeo+ Laser System
• 00816722021816 - xeo+ SA: 2022-12-08 xeo+ SA IPL System
• 00816722022813 - Limelight: 2022-12-08 Limelight IPL Handpiece for xeo+/xeo+ SA
• 00816722022820 - Prowave: 2022-12-08Prowave IPL Handpiece for xeo+/xeo+ SA
• 00816722022820 - Prowave: 2022-12-08 Prowave IPL Handpiece for xeo+/xeo+ SA
• 00816722022837 - Titan: 2022-12-08 Titan IPL Handpiece for xeo+/xeo+ SA
• 00816722022844 - Pearl Fractional: 2022-12-08 Pearl Fractional Laser Handpiece for xeo+/xeo+ SA