Vela SA applicator

Basic Information

• Brand Name: Vela SA applicator
• Primary DI: 07290109951348
• Version / Model: AS38211R
• Catalog Number: AS38211R
• Company Name: SYNERON MEDICAL LTD
• Labeler DUNS: 532685716
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: d5446045-51f0-4cd1-b177-f3babfa7cb3b
• Distribution End Date: 2023-06-21

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUV	Massager, Vacuum, Light Induced Heating	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44832	Multi-modality skin contouring system	An assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290109951348	GS1