Device Classification Name |
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
|
510(k) Number |
K150138 |
Device Name |
Aspen Laser Systems Therapy Laser System |
Applicant |
ASPEN LASER SYSTEMS, LLC |
316 CALIFORNIA AVENUE, SUITE 788 |
RENO,
NV
89509
|
|
Applicant Contact |
PAUL SCHWEN |
Correspondent |
ASPEN LASER SYSTEMS, LLC |
970 SOUTH DAWSON WAY #14 |
AURORA,
CO
80012
|
|
Correspondent Contact |
A. BRAUN HENDERSON |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/22/2015 |
Decision Date | 05/08/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|