Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K142638 |
Device Name |
ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) |
Applicant |
InnovaQuartz LLC |
23030 North 15th Ave |
Phoenix,
AZ
85027 -1315
|
|
Applicant Contact |
Stephen Griffin |
Correspondent |
InnovaQuartz LLC |
23030 North 15th Ave |
Phoenix,
AZ
85027 -1315
|
|
Correspondent Contact |
Stephen Griffin |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/17/2014 |
Decision Date | 12/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|