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FOTONA D.O.O.

Slovenia · Ljubljana

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 0Class II 9Class III 0

plus 18 registration records and 16 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

7active device licences

Class III 7

21 including historic records

TWTaiwanTFDA

15valid device licences

Class I 1Class II 14

SGSingaporeHSA SMDR

11device registrations

CLASS B 1CLASS C 10

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

5active ARTG entries

IIa 1IIb 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States18 registration records, 16 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: FOTONA D.O.O.

FDA 510(k) clearances by year

22017

12018

12019

32020

22021

22022

22023

22024

12025

FDA listed device types

showing 8 of 9

Lamp, Infrared, Therapeutic Heating 1Stimulator, Muscle, Powered 1Electromagnetic Stimulator, Pain Relief 1Stimulator, Electrical, Non-Implantable, For Incontinence 1Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1Powered Laser Surgical Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241785	StarFormer (M008-3T)	2025-03-27
US	K242202	LightWalker Laser System Family	2024-08-23
US	K234061	StarFormer	2024-07-01
BR	81504799036	FOTONA STARFORMER	Class II
CA	62898	FIDELIS ER: YAG SURGICAL LASER SYSTEM	Class III
CA	69237	DUALIS XP PLUS ND: YAG LASER SYSTEM	Class III
CA	69280	DUALIS XS ER: YAG LASER	Class III

FOTONA D.O.O.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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