Reaction™ VRE0110

GUDID 07290016746303

Reaction™

VIORA LTD

Multi-modality skin contouring system

• Primary Device ID: 07290016746303
• NIH Device Record Key: f83b7e2c-5fab-4bb2-b9c5-bbcf86e0f50c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reaction™
• Version Model Number: VRE0110
• Catalog Number: VRE0110
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016746303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090221

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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

• 07290016746006 - V30 Console: 2018-07-06 V30 Console
• 07290016746013 - V20 Console: 2018-07-06 V20 Console
• 07290016746020 - V10 Console: 2018-07-06 V10 Console
• 07290016746037 - V- IPL Handpiece: 2018-07-06 V- IPL Handpiece
• 07290016746044 - V-IPL HP Basic: 2018-07-06 V-IPL HP Basic
• 07290016746051 - V-IPL HP Full: 2018-07-06 V-IPL HP Full
• 07290016746068 - V-IPL HP Extended: 2018-07-06 V-IPL HP Extended
• 07290016746075 - V-IPL Filter HR-630: 2018-07-06 V-IPL Filter HR-630