Usa Laser Biotech, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3, LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System, NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Usa Laser Biotech, Inc. Physical Medicine ✕
6 devices
Cleared
Jul 26, 2016
Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3
Physical Medicine
89d
Cleared
Jul 05, 2016
LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp...
Physical Medicine
91d
Cleared
Feb 17, 2011
NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM,...
Physical Medicine
225d
Cleared
Oct 28, 2009
NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980
Physical Medicine
139d
Cleared
Nov 30, 2005
LUMINA 1600, 3300 AND 6600 SYSTEMS
Physical Medicine
57d
Cleared
Nov 17, 2004
IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40,...
Physical Medicine
89d