Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K020839 |
Device Name |
QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL |
Applicant |
LUMENIS, INC. |
P.O. BOX 405 |
ANGELS CAMP,
CA
95221
|
|
Applicant Contact |
ALAN L VOSS |
Correspondent |
LUMENIS, INC. |
P.O. BOX 405 |
ANGELS CAMP,
CA
95221
|
|
Correspondent Contact |
ALAN L VOSS |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/15/2002 |
Decision Date | 10/11/2002 |
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
|
|
|