Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K050317 |
Device Name |
BURANE XL |
Applicant |
WAVELIGHT LASER TECHNOLOGIE AG |
AM WOLFSMANTEL 5 |
ERLANGEN,
DE
91058
|
|
Applicant Contact |
ALEXANDER POPP |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
WILLIAM J SAMMONS |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/09/2005 |
Decision Date | 02/24/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|