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Neauvia Cell

FDA UDI

Class II (US FDA UDI)

by El.en. Spa

Identity

Trade Name
NEAUVIA CELL FDA UDI
Generic Name
Microwave hyperthermia system applicator, extracorporeal FDA UDI
Device Name
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. FDA UDI
Model / Reference
M116I1 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
M116I1 FDA UDI
Primary DI / UDI-DI
08057017760511 FDA UDI
510(k) Number
K183371 FDA UDI
FDA Product Code
PBX FDA UDI
GMDN Term
Microwave hyperthermia system applicator, extracorporeal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Microwave hyperthermia system applicator, extracorporeal

Neauvia Cell by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microwave hyperthermia system applicator, extracorporeal.

Cleared under the same submission

K183371 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
El.en. Spa

Sources (1)

  • FDA UDI 1d2b012d-19d7-429a-908f-85b7759b0e6e 36 fields · synced Jun 9, 2026