Titan

GUDID 00816722022837

Titan IPL Handpiece for xeo+/xeo+ SA

CUTERA, INC.

Multi-modality skin contouring system applicator, infrared light Multi-modality skin contouring system applicator, infrared light Multi-modality skin contouring system applicator, infrared light Multi-modality skin contouring system applicator, infrared light Multi-modality skin contouring system applicator, infrared light Multi-modality skin contouring system applicator, infrared light Multi-modality skin contouring system applicator, infrared light Multi-modality skin contouring system applicator, infrared light

• Primary Device ID: 00816722022837
• NIH Device Record Key: 994e690d-fcb0-4281-a3bc-59ad27e5b84b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Titan
• Version Model Number: Titan
• 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	00816722022837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033768

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2022-12-08 Prowave IPL Handpiece for xeo+/xeo+ SA
• 00816722022837 - Titan: 2022-12-08Titan 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
• 00816722022479 - truSculpt 2 RF handpiece: 2022-11-22 truSculpt 2 cm^2 handheld handpiece for use with truSculpt iD RF device