Sectum Precise (Face) Applicator

FDA UDI

Class II (US FDA UDI)

by Neauvia North America, Inc

Identity

Trade Name: Sectum Precise (Face) Applicator FDA UDI
Generic Name: Radio-frequency skin/body contouring system FDA UDI
Model / Reference: 300-1302 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850017374133 FDA UDI
510(k) Number: K202780 FDA UDI
FDA Product Code: GEI FDA UDI
PBX FDA UDI
GMDN Term: Radio-frequency skin/body contouring system 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Radio-frequency skin/body contouring system

Sectum Precise (Face) Applicator by Neauvia North America, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K202780 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Neauvia North America, Inc

Sources (1)

FDA UDI 758d3be6-3a65-4dd2-854a-2738fd571b6d 33 fields · synced May 31, 2026