Company ยท US
Lumitex, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2012. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2019 | Lumitex Inc Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M122506 Terminated |
LBI | K120820 |
| Sep 3, 2009 | Lumitex Inc 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 inte Terminated |
FDG | None listed |