Usa Laser Biotech, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | July 26, 2016 |
| K160947 | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp | July 5, 2016 |
| K101893 | NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO I | February 17, 2011 |
| K091726 | NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 | October 28, 2009 |
| K052814 | LUMINA 1600, 3300 AND 6600 SYSTEMS | November 30, 2005 |
| K042256 | IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 | November 17, 2004 |