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LUMITEX, INC.

US

Last updated May 23, 2026

What LUMITEX, INC. makes

Lumitex, Inc. manufactures surgical fibreoptic lighting solutions, including retractors with integrated illumination for spinal and orthopedic procedures, reusable and disposable light cables, and adaptors for compatibility with third-party systems. The company also produces open surgical site lights for direct illumination of internal tissues. Additionally, it supplies phototherapy blankets and pads designed for neonatal care.

The portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the FDA’s 510(k) and UDI registries. Lumitex, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Lumitex, Inc. manufacture?

Lumitex, Inc. specializes in surgical fibreoptic lighting solutions. This includes retractors with built-in illumination for spinal and orthopedic surgeries, reusable and disposable fibreoptic light cables, adaptors for third-party surgical systems, and open surgical site lights for direct internal tissue illumination. The company also produces phototherapy blankets and pads for neonatal care, which use light therapy to treat conditions like jaundice.

Where is Lumitex, Inc. based, and does its location affect its regulatory standing?

Lumitex, Inc. is headquartered in the United States. The company’s location influences its regulatory framework, as it operates under FDA guidelines. Since the FDA oversees medical device authorization in the U.S., Lumitex’s devices are listed in the FDA’s 510(k) and UDI registries, reflecting their compliance with U.S. regulatory requirements for Class I and Class II devices.

Which regulatory registries list Lumitex, Inc.’s devices, and why?

Lumitex, Inc.’s devices are recorded in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) submissions are required for Class II devices to demonstrate substantial equivalence to a predicate device, while the UDI system ensures traceability and transparency in the supply chain. These registries help track authorized devices and their compliance with U.S. regulations.

How are Lumitex, Inc.’s devices classified under FDA regulations, and what does that mean?

Lumitex, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices are generally low-risk and subject to general controls, while Class II devices require additional premarket notification (510(k)) to ensure safety and effectiveness. The classification determines the regulatory pathway, with Class II devices requiring more rigorous review due to their higher risk potential compared to Class I.

What distinguishes Lumitex, Inc.’s fibreoptic lighting solutions from other surgical lighting products?

Lumitex, Inc. focuses on specialized fibreoptic lighting tailored for surgical precision, particularly in spinal and orthopedic procedures. Unlike general surgical lights, their products integrate illumination directly into retractors, cables, and adaptors, ensuring targeted lighting for complex surgeries. This design reduces shadows and improves visibility in tight or hard-to-reach areas, while phototherapy units provide controlled light therapy for neonatal care, addressing a distinct medical need.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
108631797

Catalogue (124)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
Lumitex Medical Devices Adapter - Wolf 012143
FDA UDI
Class IActive
Thompson Surgical Instruments Lite Path Integrated Double 13mm 40040
EUDAMEDFDA UDI
Class IActive
Lumitex Surgical Light Cable 006424
FDA UDI
Class IUnknown
Genesys Spine Surgical Light Cable 011919
FDA UDI
Class IUnknown
Lumitex Medical Devices Adapter - ACMI 012140
FDA UDI
Class IActive
Genesys Spine Surgical Light Cable 011918
FDA UDI
Class IUnknown
Thompson Surgical Instruments Flatmat 25" 012525
FDA UDI
Class IActive
Lumitex MD Fiber Optic Cable, Bifurcated 4mm ACMI 012004
FDA UDI
Class IActive
Zimmer Biomet - AccuVision Blad 18mm x .33 Illuminated 007103
FDA UDI
Class IUnknown
LESSpine Innovations Malleable Illuminator 010104
FDA UDI
Class IActive
Pioneer - Fiber Optic Cable - Bifurcated 008659
FDA UDI
Class IUnknown
Novus N-Sight Disposable Surgical Light 010816
FDA UDI
Class IActive
CoreLink Disposable Ring Clip 26mm 6460-032
FDA UDI
Class IActive
Alphatec Spine 3mm Universal Reusable Light Cable 006963
FDA UDI
Class IActive
Thompson Surgical Instruments Medium Lightmat 50mm 012527
FDA UDI
Class IActive
Bilisoft 2.0 011559
FDA UDI
Class IIActive
Zimmer Biomet Timberline Lateral Fusion System Wave Guide 8735-0042
EUDAMEDFDA UDI
Class IActive
Camber Spine Technologies MIS Surgical Illuminator MDP-153-001
FDA UDI
Class IActive
Lattus Spine Surgical Illuminator LAT0011
FDA UDI
Class IActive
Camber Spine OLIF Surgical Illuminator 012268
FDA UDI
Class IActive
Pioneer Surgical Universal Fiber Optic Cable 008865
FDA UDI
Class IUnknown
Lulmitex Neonatal Transilluminator K912747
FDA 510(k)
Class IActive
Giraffe Blue Spot Pt Lite K120820
FDA 510(k)
Class IIActive
Bilisoft Phototherapy System K053568
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Lumitex, Inc. has two FDA recall records, both initiated in 2009 and 2019 respectively, with both currently marked as terminated. The first involved an adhesive used in the LightMat retractor system that did not meet specified medical-grade and sterilization requirements. The second concerned a potential issue with light output in systems produced between 2014 and January 2018, attributed to exposure of the light pipe to elevated temperatures.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Dec 11, 2019Z-0923-2020—terminated

There is a potential for some systems built between 2014 and Jan 2018 to have a light output falling below the recommended minimum output. This problem has been associated with exposure of the light pipe to elevated temperatures, which is contra-indicated in the Operation, Maintenance, and Service Manual.

Jul 1, 2009Z-1998-2009—terminated

Adhesive which is used to attach LightMat to retractor may not have been tested to Medical standards. The vendor provided an adhesive strip that did not conform to Lumitex specifications. The adhesive strip provided may not have met Lumitex requirements to be medical grade, EtO compatible, and biocompatible.