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510k Database
Manufacturers
US
Isolux, LLC
Medical Device Manufacturer
·
US , Naples , FL
Isolux, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2005
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Isolux, LLC
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 21, 2016
OptiLux LED Illuminator
K163185
·
HBI
General & Plastic Surgery
·
7d
Cleared
Sep 24, 2010
ISOLED AC-POWERED LED HEADLIGHT SYSTEM
K102266
·
FST
General & Plastic Surgery
·
45d
Cleared
Oct 31, 2005
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
K052979
·
HBI
General & Plastic Surgery
·
7d
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3
General & Plastic Surgery
3