IsoLED Plus+ LED HL

FDA UDI

Class II (US FDA UDI)

by Medical Illumination International, Inc

Identity

Trade Name: IsoLED Plus+ LED HL FDA UDI
Generic Name: Head-worn lamp FDA UDI
Device Name: IsoLED Plus+ LED HL, w/ AC Power Pack FDA UDI
Model / Reference: IL-2410-02 FDA UDI
Description: IsoLED Plus+ LED HL, w/ AC Power Pack FDA UDI

Identifiers

Primary DI / UDI-DI: 00816835024032 FDA UDI
FDA Product Code: FCT FDA UDI
HPP FDA UDI
GMDN Term: Head-worn lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4335 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Head-worn lamp

IsoLED Plus+ LED HL by Medical Illumination International, Inc — 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: Medical Illumination International, Inc

Sources (1)

FDA UDI 7264d8f2-e1d0-4bdb-9e2e-608ffe5b544a 33 fields · synced Jun 8, 2026