VelaShape II system FG70321R

GUDID 07290109951539

Vela Shape II System 115V, Packaged

SYNERON MEDICAL LTD

Multi-modality skin contouring system

• Primary Device ID: 07290109951539
• NIH Device Record Key: 4cf60ea0-22e3-4f77-86d8-d930e5b21406
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VelaShape II system
• Version Model Number: FG70321R
• Catalog Number: FG70321R
• Company DUNS: 532685716
• Company Name: SYNERON MEDICAL 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109951539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071872

FDA Product Code

• NUV: Massager, Vacuum, Light Induced 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: 2016-09-25

On-Brand Devices [VelaShape II system]

• 07290109951546: Vela Shape II System 100V, Packaged
• 07290109951539: Vela Shape II System 115V, Packaged