The following data is part of a premarket notification filed by Aspen Laser Systems, Llc with the FDA for Aspen Laser Systems Therapy Laser System.
| Device ID | K150138 |
| 510k Number | K150138 |
| Device Name: | Aspen Laser Systems Therapy Laser System |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | ASPEN LASER SYSTEMS, LLC 316 CALIFORNIA AVENUE, SUITE 788 Reno, NV 89509 |
| Contact | Paul Schwen |
| Correspondent | A. Braun Henderson ASPEN LASER SYSTEMS, LLC 970 SOUTH DAWSON WAY #14 Aurora, CO 80012 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-22 |
| Decision Date | 2015-05-08 |