Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613462

FEI Number

1000597018

Entity Name

FOTONA D.O.O.

City/State/Country

LJUBLJANA, SI

Establishment Address

STEGNE 7,, LJUBLJANA 1000, SI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FOTONA D.O.O. (Owner Number: 9032993)

Owner / Operator Contact Address

STEGNE 7, LJUBLJANA, SI-061 1000, SI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K050293

PMA Number

N/A

All Registered Proprietary Names

Fotona XP Nd:YAG Laser System Family AvalancheLase Family SkyPulse Laser Platform Fotona XP Nd:YAG Laser System Family StarFormer StarWalker LightWalker Laser System Family Fotona Lightwalker Laser System Family QuantumStar StarFormer (M008-3T) Fotona Dynamis LightWalker Laser System Family Fotona XP Plus Nd:YAG Family

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2011-10-10
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-02-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-03-30
PDZ	Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	General, Plastic Surgery	Class 2	878.4810	2013-11-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-11-08
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-07-16
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2024-07-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2020-11-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2019-09-27
NVK	Laser, Dental, Soft Tissue	General, Plastic Surgery	Class 2	878.4810	2019-09-27
PDZ	Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis	General, Plastic Surgery	Class 2	878.4810	2019-09-27
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2019-09-27
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2017-12-08
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-04-01
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2025-04-01
QPL	Electromagnetic Stimulator, Pain Relief	Neurology	Class 2	882.5890	2025-04-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-04-24
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2015-04-24
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-06-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2011-12-07

Official Correspondent

MARKO BERDAJS

US Agent Details

Jeremy Desrosiers Business: Fotona LLC Email: management@fotona.org Phone: (972) 5989000

Related Public Records

Same Entity

FOTONA D.O.O.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

Similar Registrations

Registration Number	Establishment Name	Location
3014980477	ELEMENIC CO., LTD.	Seoul, KR
3009462521	Oncore Manufacturing, LLC dba NEOTech	Fremont, CA, US
3033905238	BEIJING MEGA BEAUTY TECHNOLOGY CO.,LTD.	Beijing, CN
3014384451	LAMEDITECH CO., LTD.	Seoul, KR
3010273372	WEIFANG KM ELECTRONICS CO., LTD	Weifang Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613462. Last updated year: 2026. Please use registration number 9613462 when referencing this establishment in official correspondence.