Lumix Cw

FDA UDI

Class II (US FDA UDI)

by Fisioline Srl

Identity

Trade Name: LUMIX CW FDA UDI
Generic Name: Skin laser scanner FDA UDI
Device Name: LASER THERAPY UNIT LUMIX CW with 2 WAVELENGTH (650nm+1064nm) FDA UDI
Model / Reference: LCW202 FDA UDI
Description: LASER THERAPY UNIT LUMIX CW with 2 WAVELENGTH (650nm+1064nm) FDA UDI

Identifiers

Primary DI / UDI-DI: 08057949170181 FDA UDI
510(k) Number: K052814 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 — 10 Millimeter FDA UDI
Lumen/Inner Diameter — 650 Nanometer FDA UDI
Lumen/Inner Diameter — 1064 Nanometer FDA UDI

Category: Skin laser scanner

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

Similar devices

Also classified as Skin laser scanner.

Scanning System for LS-6000 — BTL Industries, Inc. · Class II
UltraScan CPG — Lumenis Be, Inc. · Class II
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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Fisioline Srl

Sources (1)

FDA UDI 6e89a51d-9c4f-4661-854e-34cf00084311 36 fields · synced May 31, 2026