Tixel TXLD0002

GUDID 07290117524008

Tixel Back Unit

NOVOXEL LTD

Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system Thermo-mechanical skin surface treatment system

• Primary Device ID: 07290117524008
• NIH Device Record Key: 2da5b82a-1901-43c5-8ac2-bd9694b01573
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tixel
• Version Model Number: TXLD0002
• Catalog Number: TXLD0002
• Company DUNS: 600275858
• Company Name: NOVOXEL LTD
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	07290117524008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202988

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2021-11-01
• Device Publish Date: 2021-10-24

Devices Manufactured by NOVOXEL LTD

• 07290117524046 - Tixel C: 2021-11-22
• 07290117524053 - Tixel Handpiece: 2021-11-22 To be used with Tixel C Model MSTX0002
• 07290117524060 - Tixel-Small Tip Handpiece: 2021-11-22 To be used with Tixel C MSTX0002 Model
• 07290117524008 - Tixel: 2021-11-01Tixel Back Unit
• 07290117524008 - Tixel: 2021-11-01 Tixel Back Unit
• 07290117524015 - Tixel Handpiece: 2021-11-01 Standard Handpiece used with TXLD0002
• 07290117524022 - Tixel Periorbital Handpiece: 2021-11-01 Handpiece used with Tixel System TXLD0002