Data / Medical devices / United States / Lumitex Medical Devices, Inc.
Lumitex Medical Devices, Inc.: FDA-registered device maker in Brecksville, OH, United States, 2 510(k) clearances
Lumitex Medical Devices, Inc. is registered with the FDA (registration 1000122810) in Brecksville, OH, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 8, 2012. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1000122810
- Address
- 6611 W Snowville Rd, Brecksville, OH, United States, 44141
- Owner or operator
- Lumitex Medical Devices, Inc. (9000093)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- December 16, 1999
- Registered through
- 2026
- Brand names listed
- 013450 Lumitex Surgical Malleable Illuminator, 10040040 Thompson LitePath, 40040 Thompson Surgical Instruments Lite Path Integrated D 13mm, 40041 Thompson Surgical Instruments Lite Path Adhesive S 120mm, 4WEB-OA15S-LC 4WEB Medical OA51S Surgical Illuminator, Advanced Medical Solutions 3.5mm ACMI Bifurcated Reusebale Light Cable, Advanced Medical Soultions Anterior Access Kit 4mm MAX Cable Diameter, Alphatec Spine 3mm Universal Reusable Light Cable and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Intraoral Phototherapy Device | SGQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Retractor, Fiberoptic | FDG | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Unit, Neonatal Phototherapy | LBI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 8, 2012 | K120820 | GIRAFFE BLUE SPOT PT LITE | LBI | Substantially Equivalent | Lumitex, Inc. | accessdata.fda.gov |
| April 17, 2006 | K053568 | BILISOFT PHOTOTHERAPY SYSTEM | LBI | Substantially Equivalent | Lumitex, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 11, 2019 | 84562 | Class II | Terminated | Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M122506 | 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. | accessdata.fda.gov |
| July 1, 2009 | 52817 | Not yet classified | Terminated | Ultra-Thin LightMat Surgical Illuminator, Disposable one time use. Model Number: UA2550, Exp Date: 2012-05. Product is packaged in individual sterile pouch w/5 pouches per box. The LightMat is intended for the illuminati | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Neonatal Phototherapy
- All makers of Bedding, Disposable, Medical
- All makers of Retractor, Fiberoptic
Updated June 8, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.