Genesis Plus

GUDID 00816722021205

Genesis Plus Laser System

CUTERA, INC.

Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system

• Primary Device ID: 00816722021205
• NIH Device Record Key: d215fc54-b1ef-49d7-967d-c6cbc8f0552d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis Plus
• Version Model Number: Genesis Plus
• 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

Customer Support Contacts

• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com
• Phone: 1 415 657-5500
• Email: info@cutera.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816722021205 [Primary]

FDA Product Code

• PDZ: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-09-23

Devices Manufactured by CUTERA, INC.

• 00816722022806 - Acutip: 2023-05-23 Acutip IPL Handpiece for xeo+/xeo+ SA
• 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: 2022-12-08 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