The following data is part of a premarket notification filed by Usa Laser Biotech Inc. with the FDA for Nexus Xpulse 805 Ir Lamp System, Nexus Xpulse 980 Ir Lamp System, Model 805, 980.
| Device ID | K091726 |
| 510k Number | K091726 |
| Device Name: | NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | USA LASER BIOTECH INC. 12101 CULLEN BLVD., # A Houston, TX 77047 |
| Contact | Joyce Heinrich |
| Correspondent | Joyce Heinrich USA LASER BIOTECH INC. 12101 CULLEN BLVD., # 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 | 2009-06-11 |
| Decision Date | 2009-10-28 |
| Summary: | summary |