Platinum LED Therapy Lights

FDA UDI

Class II (US FDA UDI)

by Platinum Led Holdings Llc

Identity

Trade Name: Platinum LED Therapy Lights FDA UDI
Generic Name: Blue/red/infrared phototherapy lamp FDA UDI
Device Name: BIO900NIR FDA UDI
Model / Reference: BIO900NIR FDA UDI
Description: BIO900NIR FDA UDI

Identifiers

Catalog Number: BIO900NIR FDA UDI
Primary DI / UDI-DI: B842BIO900NIR0 FDA UDI
FDA Product Code: ILY FDA UDI
GMDN Term: Blue/red/infrared phototherapy lamp 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 33 Pound FDA UDI

Category: Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights by Platinum Led Holdings Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
COMLAX — T&L HEALTHCARE Co., Ltd · Class II
Celluma — BioPhotas, 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

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Manufacturer

Manufacturer: Platinum Led Holdings Llc

Sources (1)

FDA UDI f5d145a4-d4e5-4540-9ef2-1d3422de2f21 37 fields · synced May 31, 2026