Prof Beauty

FDA UDI

Class II (US FDA UDI)

by Beautex Llc

Identity

Trade Name: Prof Beauty FDA UDI
Generic Name: Dermatological diode laser system FDA UDI
Model / Reference: ICB-MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00860010319017 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dermatological diode laser system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 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

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

Sterilization Method

High-level Disinfectant FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Dermatological diode laser system

Prof Beauty by Beautex Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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TwinScan 808/755 Laser System — GME German Medical Engineering GmbH · 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

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Manufacturer

Manufacturer: Beautex Llc

Sources (1)

FDA UDI ff61f78c-b66d-4423-960f-d6494121da59 32 fields · synced May 30, 2026