The following data is part of a premarket notification filed by Usa Laser Biotech Inc. with the FDA for Ir Heat Lamp Systems: Icl 15 Hfpl System, Icl 60 Plus Hfpl System (models 40, 100 And 250), Icl 100 Activo Scanner Syste.
| Device ID | K042256 |
| 510k Number | K042256 |
| Device Name: | IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | USA LASER BIOTECH INC. 12101 CULLEN BLVD., # A Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. 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 | 2004-08-20 |
| Decision Date | 2004-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08057949171850 | K042256 | 000 |
| 08057949171843 | K042256 | 000 |
| 08057949171911 | K042256 | 000 |