Refurbished VelaSmooth AS20341R

GUDID 07290109951294

Refurbished ,Vela- Pack. 115Vac Assy

SYNERON MEDICAL LTD

Multi-modality skin contouring system

• Primary Device ID: 07290109951294
• NIH Device Record Key: 5469346f-60de-4862-b614-6f8eb63ff21f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Refurbished VelaSmooth
• Version Model Number: AS20341R
• Catalog Number: AS20341R
• 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	07290109951294 [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: 2016-09-22

On-Brand Devices [Refurbished VelaSmooth]

• 07290109951317: Refurbished ,Vela- Pack.100Vac Assy
• 07290109951294: Refurbished ,Vela- Pack. 115Vac Assy