Lumitex Medical Devices, Inc.

Brecksville, OH, US

Lumitex Medical Devices, Inc. appears in FDA device records in Brecksville, OH. FDA records list 3 510(k) clearances between 1991-12-24 and 2012-06-08, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Lumitex Medical Devices, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Lumitex, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 3 510(k) clearances for Lumitex Medical Devices, Inc. between 1991 and 2012. The busiest year on record is 1991, with 1. The most recent is 2012, with 1.

Clearances by year, as a table

510(k) clearance decisions for Lumitex Medical Devices, Inc., by decision year
Year	Clearances
1991	1
2006	1
2012	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K120820	GIRAFFE BLUE SPOT PT LITE	LBI	Substantially Equivalent	2012-06-08
K053568	BILISOFT PHOTOTHERAPY SYSTEM	LBI	Substantially Equivalent	2006-04-17
K912747	LULMITEX NEONATAL TRANSILLUMINATOR	HJN	Substantially Equivalent	1991-12-24

Registered establishments

FDA registered establishments for Lumitex Medical Devices, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1000122810	1000122810	Lumitex Medical Devices, Inc.	6611 W Snowville Rd, Brecksville, OH 44141 US	2026	FDG KME LBI SGQ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0923-2020	Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M1225064, M1225024, M1231622, M1236303, M1238489, M1238490, M1238492, M1238493, M1238495, M1238499, M1238503, M1238505, M1238507, M1238508, 2063860-001, 2063862-001, 2063870-001, 2063873-001, 2063874-001, 2071393-001, 2080916-001, 2089424-001	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.	Class II	2019-12-11	Terminated
Z-1998-2009	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 illumination of surgical procedures, particularly where deep cavities or adjacent tissues limit outside light in the surgical field.	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.		2009-07-01	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain