The following data is part of a premarket notification filed by Aspen Laser Systems, Llc with the FDA for Velasii Therapy Laser System.
| Device ID | K142078 |
| 510k Number | K142078 |
| Device Name: | VELASII THERAPY LASER SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | ASPEN LASER SYSTEMS, LLC 970 SOUTH DAWSON WAY #14 Aurora, CO 80012 |
| Contact | A. Braun Henderson |
| Correspondent | A. Braun Henderson ASPEN LASER SYSTEMS, LLC 970 SOUTH DAWSON WAY #14 Aurora, CO 80012 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-31 |
| Decision Date | 2014-10-30 |