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LIPOcel

FDA UDIEUDAMED

Class II (US FDA UDI)

by Jeisys Medical Incorporated

Identity

Trade Name
LIPOcel FDA UDI
Generic Name
Ultrasound hyperthermia system transducer, extracorporeal FDA UDI
Device Name
Focused Ultrasound for tissue heat or mechanical cellular disruption FDA UDI
Model / Reference
LIPOcel FDA UDI
Description
Focused Ultrasound for tissue heat or mechanical cellular disruption FDA UDI

Identifiers

Primary DI / UDI-DI
08800020100009 FDA UDI
510(k) Number
K181896 FDA UDI
FDA Product Code
OHV FDA UDI
GMDN Term
Ultrasound hyperthermia system transducer, extracorporeal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4590 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: Ultrasound hyperthermia system transducer, extracorporeal

LIPOcel by Jeisys Medical Incorporated — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound hyperthermia system transducer, extracorporeal.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jeisys Medical Incorporated

Sources (2)

  • FDA UDI fe2108be-46b0-4f60-9c9a-db5c9fa9b8cf 34 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026