Vela SA applicator AS38211R

GUDID 07290109951348

Vela SA Appl.Pack.+ Disp.Parts for Appl.

SYNERON MEDICAL LTD

Multi-modality skin contouring system

• Primary Device ID: 07290109951348
• NIH Device Record Key: d5446045-51f0-4cd1-b177-f3babfa7cb3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vela SA applicator
• Version Model Number: AS38211R
• Catalog Number: AS38211R
• 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	07290109951348 [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

Devices Manufactured by SYNERON MEDICAL LTD

• 07290109952703 - SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III: 2020-03-31 SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
• 07290109952857 - Intima Sterile 2 Internal + 1 External HP, Accessories Kit: 2020-02-10 Intima Sterile 2 Internal + 1 External HP, Accessories Kit
• 07290109952864 - eTwo System: 2020-02-10 eTwo System
• 17290109952724 - Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima: 2020-02-10 Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
• 17290109952823 - External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima: 2020-02-10 External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
• 17290109950379 - Internal, CO2RE Intima: 2019-02-07 Internal, CO2RE Intima
• 07290109950167 - Purple swivel lens: 2019-02-07 Purple swivel lens
• 07290109950273 - Lens, Gold & Silver: 2019-02-07 Lens, Gold & Silver Assy, CO2RE