NEAUVIA CELL

Basic Information

• Brand Name: NEAUVIA CELL
• Primary DI: 08057017760511
• Version / Model: M116I1
• Catalog Number: M116I1
• Company Name: EL.EN. SPA
• Labeler DUNS: 436887608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-06
• Public Version: 1
• Public Version Date: 2020-03-16
• Public Version Status: New
• Public Device Record Key: 1d2b012d-19d7-429a-908f-85b7759b0e6e

Device Description

The NEAUVIA CELL is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• 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
PBX	Massager, Vacuum, Radio Frequency Induced Heat	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40791	Microwave hyperthermia system applicator, extracorporeal	A component of a microwave hyperthermia system designed to direct and deliver microwave energy used to produce a systemic or local heating effect. It is typically mounted on a floor, wall, or ceiling suspension that allows the operator to position the microwave source from a point outside the patient's body. The applicator assembly includes cables and connectors that interface with the energy-generating unit of the hyperthermia system during treatments. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08057017760511	GS1

Premarket Submissions

Submission Number	Supplement Number
K183371	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius