Lumix 250

FDA UDI

Class II (US FDA UDI)

by Fisioline Srl

Identity

Trade Name: LUMIX 250 FDA UDI
Generic Name: Skin laser scanner FDA UDI
Device Name: LASER THERAPY UNIT LUMIX 250 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 5W FDA UDI
Model / Reference: LUMIX 250 FDA UDI
Description: LASER THERAPY UNIT LUMIX 250 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 5W FDA UDI

Identifiers

Catalog Number: LUMIX250R2 FDA UDI
Primary DI / UDI-DI: 08057949170044 FDA UDI
510(k) Number: K042256 FDA UDI
FDA Product Code: ILY FDA UDI
GMDN Term: Skin laser scanner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 20 Millimeter FDA UDI
Lumen/Inner Diameter — 910 Nanometer FDA UDI
Lumen/Inner Diameter — 650 Nanometer FDA UDI

Category: Skin laser scanner

Lumix 250 by Fisioline Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin laser scanner.

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DeepFX ™ Microscanner — Lumenis Be, Inc. · Class II
EliteScan — Quanta System Spa · Class II
OptiScan — Quanta System Spa · Class II
UltraScan CPG — Lumenis Be, Inc. · Class II
OptiScan — Quanta System Spa · Class II
DeepFX ™ Microscanner — Lumenis Be, Inc. · Class II

Cleared under the same submission

K042256 also covers:

LUMIX 100 — FISIOLINE SRL
LUMIX 2 — FISIOLINE SRL

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: Fisioline Srl

Sources (1)

FDA UDI 2d4dac65-af8f-4bc8-99d6-ba46d0e50a3d 38 fields · synced May 30, 2026