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Biosonic

FDA UDI

Class II (US FDA UDI)

by Biosonic Technologies, LLC

Identity

Trade Name
Biosonic FDA UDI
Generic Name
Transcutaneous electrical stimulation probe FDA UDI
Device Name
Microcurrent Facial Sculpting FDA UDI
Model / Reference
Facial Sculpting FDA UDI
Description
Microcurrent Facial Sculpting FDA UDI

Identifiers

Primary DI / UDI-DI
00860558000422 FDA UDI
510(k) Number
K130065 FDA UDI
FDA Product Code
NFO FDA UDI
GMDN Term
Transcutaneous electrical stimulation probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 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

No

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

No

FDA UDI

Category: Transcutaneous electrical stimulation probe

Biosonic by Biosonic Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous electrical stimulation probe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biosonic Technologies, LLC

Sources (1)

  • FDA UDI 882240b3-3605-429f-8c32-93db31b4e527 35 fields · synced Jun 8, 2026