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QuantumStar, StarFormer

FDA UDI

Class II (US FDA UDI)

by Fotona D.O.O.

Identity

Trade Name
QuantumStar, StarFormer FDA UDI
Generic Name
Deep-tissue electromagnetic stimulation system, professional FDA UDI
Device Name
It is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the handheld applicators and in the back of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current. This current stimulates neurons and activates muscle contractions. FDA UDI
Model / Reference
M008-3T FDA UDI
Description
It is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the handheld applicators and in the back of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current. This current stimulates neurons and activates muscle contractions. FDA UDI

Identifiers

Primary DI / UDI-DI
03830054238138 FDA UDI
510(k) Number
K234061 FDA UDI
K241785 FDA UDI
FDA Product Code
IPF FDA UDI
NGX FDA UDI
KPI FDA UDI
QPL FDA UDI
GMDN Term
Deep-tissue electromagnetic stimulation system, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
876.5320 FDA UDI
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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Deep-tissue electromagnetic stimulation system, professional

QuantumStar, StarFormer by Fotona D.O.O. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Deep-tissue electromagnetic stimulation system, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fotona D.O.O.

Sources (1)

  • FDA UDI 5582e6ce-9491-46bb-9154-89b8802bfcad 35 fields · synced May 30, 2026