Dermalux

FDA UDI

Class II (US FDA UDI)

by Aesthetic Technology, Ltd.

Identity

Trade Name: Dermalux FDA UDI
Generic Name: Blue/red/infrared phototherapy lamp FDA UDI
Device Name: The Dermalux® Flex MD is a Medical Device for use on a treatment bed/surface. The device emits specific wavelengths of low level, narrow band light for the treatment of certain cosmetic, dermatological and medical indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm. FDA UDI
Model / Reference: Flex MD FDA UDI
Description: The Dermalux® Flex MD is a Medical Device for use on a treatment bed/surface. The device emits specific wavelengths of low level, narrow band light for the treatment of certain cosmetic, dermatological and medical indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm. FDA UDI

Identifiers

Catalog Number: 1000161 FDA UDI
Primary DI / UDI-DI: 50607624600804 FDA UDI
FDA Product Code: GEX FDA UDI
ILY FDA UDI
GMDN Term: Blue/red/infrared phototherapy lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
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

FDA UDI

Over-the-Counter

Yes

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

Category: Blue/red/infrared phototherapy lamp

Dermalux by Aesthetic Technology, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Aesthetic Technology, Ltd.

Sources (1)

FDA UDI e05199e1-0aee-46c4-89f1-17c7b0834766 34 fields · synced Jun 8, 2026