Fotona XP Max

FDA UDI

Class II (US FDA UDI)

by Fotona D.O.O.

Identity

Trade Name: Fotona XP Max FDA UDI
Generic Name: General/multiple surgical solid-state laser system FDA UDI
Device Name: The Fotona XP Max (DualisXP Plus II) laser system incorporates a treatment laser that operates in the invisible near-infrared range of the electromagnetic spectrum, and an aiming beam laser that operates in the visible range. The Variable Square Pulse (VSP) Technology implemented in the laser systems allows ultimate control of laser energy and laser pulse length. The Fotona XP Max (DualisXP Plus II) laser system incorporates the following laser sources: A long-pulse Nd:YAG laser, with a wavelength of 1064 nm An aiming beam diode laser, with a wavelength of 650 nm The Fotona XP MAX (DualisXP Plus II) Nd:YAG laser system and its accessories is indicated for use in surgical and aesthetic applications requiring the selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology. FDA UDI
Model / Reference: M001-12F FDA UDI
Description: The Fotona XP Max (DualisXP Plus II) laser system incorporates a treatment laser that operates in the invisible near-infrared range of the electromagnetic spectrum, and an aiming beam laser that operates in the visible range. The Variable Square Pulse (VSP) Technology implemented in the laser systems allows ultimate control of laser energy and laser pulse length. The Fotona XP Max (DualisXP Plus II) laser system incorporates the following laser sources: A long-pulse Nd:YAG laser, with a wavelength of 1064 nm An aiming beam diode laser, with a wavelength of 650 nm The Fotona XP MAX (DualisXP Plus II) Nd:YAG laser system and its accessories is indicated for use in surgical and aesthetic applications requiring the selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology. FDA UDI

Identifiers

Primary DI / UDI-DI: 03830054230163 FDA UDI
510(k) Number: K050293 FDA UDI
FDA Product Code: GEX 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 Max 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 80f62977-9ad0-4600-8023-036b0f3a1543 36 fields · synced May 30, 2026