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: 4-Pod LED phototherapy device. FDA UDI
Model / Reference: Tri-Wave MD MKII FDA UDI
Description: 4-Pod LED phototherapy device. FDA UDI

Identifiers

Catalog Number: 1000021 FDA UDI
Primary DI / UDI-DI: 50607624600118 FDA UDI
510(k) Number: K240222 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

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

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Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 679.7 Millimeter FDA UDI
Height — 1087.4 Millimeter FDA UDI
Width — 517.7 Millimeter FDA UDI
Weight — 55 Kilogram 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 b218ad29-7124-4064-84c8-379fd5973fe4 36 fields · synced May 30, 2026