The following data is part of a premarket notification filed by Usa Laser Biotech Inc. with the FDA for Nexus Biowave 7w Lite Ir Lamp System, Nexus Biowave 10w Lite Ir Lamp System, Nexus Biowave 30w Pro Ir Lamp System, Nexus.
| Device ID | K101893 |
| 510k Number | K101893 |
| Device Name: | NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | USA LASER BIOTECH INC. 12101 CULLEN BOULEVARD # A Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich USA LASER BIOTECH INC. 12101 CULLEN BOULEVARD # A Houston, TX 77047 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-07 |
| Decision Date | 2011-02-17 |
| Summary: | summary |