Surgical Headlight

FDA UDI

Class II (US FDA UDI)

by Gulf Fiberoptics, Inc.

Identity

Trade Name: Surgical Headlight FDA UDI
Generic Name: Head-worn fibreoptic light FDA UDI
Device Name: A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehead to provide light directly onto the field of vision during a medical or surgical procedure. The light typically consists of a magnifying lens, a reflector, and a fiber optic cable that conveys light from a connected light source. FDA UDI
Model / Reference: Premium Double Adjustable Headgear FDA UDI
Description: A fiber optic lamp mounted on a headband frame and intended to be situated on the user's forehead to provide light directly onto the field of vision during a medical or surgical procedure. The light typically consists of a magnifying lens, a reflector, and a fiber optic cable that conveys light from a connected light source. FDA UDI

Identifiers

Primary DI / UDI-DI: 00857580006379 FDA UDI
510(k) Number: K061690 FDA UDI
FDA Product Code: FST FDA UDI
GMDN Term: Head-worn fibreoptic light FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4580 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

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Lot / Batch Number

Yes

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

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Category: Head-worn fibreoptic light

Surgical Headlight by Gulf Fiberoptics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Head-worn fibreoptic light.

Sunoptic Technologies — Sunoptic Technologies · Class II
90 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
BR Surgical, LLC — BR SURGICAL LLC · Class II
105 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
90 Deg Fiber Optic HL — Medical Illumination International, Inc · Class II
BR Surgical, LLC — BR SURGICAL LLC · Class II
ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II

Cleared under the same submission

K061690 also covers:

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: Gulf Fiberoptics, Inc.

Sources (1)

FDA UDI 8bbd6ae7-ecfb-48c9-a154-bb9a2ca6fdb1 35 fields · synced Jun 8, 2026