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VOLNEWMER I tip(D)

FDA UDI

Class II (US FDA UDI)

by CLASSYS Inc.

Identity

Trade Name
VOLNEWMER I tip(D) FDA UDI
Generic Name
Radio-frequency skin contouring system applicator tip FDA UDI
Model / Reference
VLMC02502D FDA UDI

Identifiers

Primary DI / UDI-DI
08800016905434 FDA UDI
510(k) Number
K240248 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Radio-frequency skin contouring system applicator tip 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radio-frequency skin contouring system applicator tip

VOLNEWMER I tip(D) by CLASSYS Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency skin contouring system applicator tip.

Cleared under the same submission

K240248 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CLASSYS Inc.

Sources (1)

  • FDA UDI c75fd3aa-1d49-4684-926e-6ebcf0a4ea5d 33 fields · synced May 30, 2026