Fotona XP Focus

FDA UDI

Class II (US FDA UDI)

by Fotona D.O.O.

Identity

Trade Name: Fotona XP Focus FDA UDI
Generic Name: General/multiple surgical solid-state laser system FDA UDI
Device Name: The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with an undercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range. XP Focus family laser systems incorporate: A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation. An aiming semiconductor diode laser operating at a wavelength of 650 nm. The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length. FDA UDI
Model / Reference: M001-14F FDA UDI
Description: The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with an undercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range. XP Focus family laser systems incorporate: A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation. An aiming semiconductor diode laser operating at a wavelength of 650 nm. The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length. FDA UDI

Identifiers

Primary DI / UDI-DI: 03830054230170 FDA UDI
510(k) Number: K090126 FDA UDI
FDA Product Code: GEX FDA UDI
PDZ FDA UDI
GMDN Term: General/multiple surgical solid-state laser system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Fotona XP Focus by Fotona D.O.O. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fotona D.O.O.

Sources (1)

FDA UDI c7db9f24-e41d-4d29-8e75-5958ea8a2c44 36 fields · synced Jun 1, 2026