← Back to manufacturers

Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
108631797

Catalogue (124)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
CoreLink Surgical Illuminator 011058
FDA UDI
Class IActive
SeaSpine ACMI Cable Adapter 007978
FDA UDI
Class IActive
DePuy 4mm WOLF Reusable Light Cable 012514
FDA UDI
Class IActive
Black & Black - LumiView - Midi 010563
FDA UDI
Class IActive
Lumitex Surgical Light Cable 006422
FDA UDI
Class IUnknown
Black & Black - LumiView - Mini 010546
FDA UDI
Class IActive
Medacta Interntational Adapter - Wolf 011205
FDA UDI
Class IActive
Bones and Nerves Disposable Single Leg Surgical Illuminator BNS-LT 10 01-S
FDA UDI
Class IActive
Lumitex Surgical Light Cable 006241
FDA UDI
Class IUnknown
Medacta International Adapter - Storz 011206
FDA UDI
Class IActive
SpineCraft 2.8mm ACMI Reusable Light Cable 011103
FDA UDI
Class IActive
Lumitex Surgical Light Cable 005757
FDA UDI
Class IUnknown
Zimmer Biomet - Accuvision Blade Tip - 18mm 007098
FDA UDI
Class IUnknown
Surgical Light Cable 009740
FDA UDI
Class IUnknown
Medacta International Adapter - Olympus 011207
FDA UDI
Class IActive
Spinal Elements Adapter - Storz 012017
FDA UDI
Class IActive
Altus Spine Bifurcated Illuminator 012031
FDA UDI
Class IActive
Bilisoft 2.0 009791
FDA UDI
Class IIActive
Precision Spine Midline Cortical Surgical Illuminator 011652
FDA UDI
Class IActive
Koros Surgical Illuminator 7776-25
FDA UDI
Class IActive
Choice Spine Surgical Illuminator 007123
EUDAMEDFDA UDI
Class IActive
Bilisoft 2.0 009765
FDA UDI
Class IIActive
Camber Spine Technologies Intermediary Fiber Optic Cable MDP-153-002
FDA UDI
Class IActive
Zimmer Biomet - AccuVision Blade Tip - 22mm 007096
FDA UDI
Class IUnknown
Lumitex Surgical Light Cable 005366
FDA UDI
Class IUnknown
Invictus Development and Engineering Surgical Illuminator INTP-L-01
FDA UDI
Class IActive
SeaSpine STORZ Cable Adapter 007976
FDA UDI
Class IActive
In'Tech Medical SAS 40mm Surgical Illuminator 012355
EUDAMEDFDA UDI
Class IActive
Genesys Spine Surgical Illuminator 011914
FDA UDI
Class IUnknown
Alphatec Spine Olympus Cable Adaptor 73552
FDA UDI
Class IActive
Spineart Surgical Illuminator 010996
EUDAMEDFDA UDI
Class IActive
Pinnacle Spine Products 4mm ACMI Bifurcated Reusable Light Cable 009308
FDA UDI
Class IActive
Altus Spine ACMI Fiber Optic Cable 005011
FDA UDI
Class IActive
Spinal Elements - TLIF Retractor Light 012019
FDA UDI
Class IActive
Alphatec Spine Illico Illuminator 006981
FDA UDI
Class IUnknown
Globus Medical 4mm OLYMPUS Cable Adapter 006493
FDA UDI
Class IActive
Medacta International Surgical Illuminator 011202
EUDAMEDFDA UDI
Class IActive
Pinnacle Spine Products Surgical Illuminator 009077
FDA UDI
Class IActive
Lumitex Medical Devices Surgical Illuminator Cable 012267
FDA UDI
Class IActive
Precision Spine 4mm ACMI Reusable Light Cable 011071
FDA UDI
Class IActive
Zimmer Biomet - AccuVision Blad 25mm Flat 007097
FDA UDI
Class IUnknown
Precision Spine TLIF Bifurcated Surgical Illuminator 73-LC-5200
FDA UDI
Class IUnknown
Zimmer Biomet - AccuVision Blade 25mm x .33 007101
FDA UDI
Class IUnknown
Advanced Medical Solutions 3.5mm ACMI Bifurcated Reusable Light Cable AMS-0067-2
FDA UDI
Class IActive
Precision Spine TLIF Bifurcated Surgical Illuminator 73-LC-5300
FDA UDI
Class IActive
Life Spine Surgical Illuminator 009748
FDA UDI
Class IActive
Spinal Elements Adapter - Wolf 012015
FDA UDI
Class IActive
In'Tech Medical 60mm Surgical Illuminator 010810
EUDAMEDFDA UDI
Class IActive
Globus Medical 4mm WOLF Cable Adapter 006492
FDA UDI
Class IActive
Alphatec Spine - Battalion LLIF Light Cable 011856
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.