HR Hand piece VTR2001

GUDID 07290016746365

HR Hand piece

VIORA LTD

Intense pulsed light skin surface treatment system

• Primary Device ID: 07290016746365
• NIH Device Record Key: a6ecb94a-cd16-495d-946e-007af06fbb05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HR Hand piece
• Version Model Number: VTR2001
• Catalog Number: VTR2001
• Company DUNS: 514612758
• Company Name: VIORA LTD
• 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: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com
• Phone: 8884151192
• Email: CustomerCareUSA@vioramed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016746365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090399

FDA Product Code

• ONF: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by VIORA LTD

• 07290016746716 - Console: 2025-07-31 EnerJet Console
• 07290016746723 - Applicator: 2025-07-31 EnerJet Applicator
• 07290016746730 - Trolley: 2025-07-31 EnerJet Trolley
• 07290016746747 - Disposable Delivery Nozzle: 2025-07-31 EnerJet Delivery Nozzle
• 07290016746761 - Treatment Kit 2.0: 2025-07-31 EnerJet Treatment Kit
• 07290016746440 - ST Single Use Tip: 2025-06-30 ST Single Use Tip
• 07290016746495 - DermaFuse: 2025-05-29 DermaFuse console
• 07290016746679 - Brush Single-Use Tip: 2025-05-29 Brush Single-Use Tip for use with Dermafuse