Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K132989 |
Device Name |
SPEED 808 DIODE LASER SYSTEM |
Applicant |
BEIJING TOPLASER TECHNOLOGY CO., LTD. |
EAST 3RD FL, BLDG M7 |
# 1 JIUXIANQIAO EAST RD |
CHAOYANG DISTRICT, BEIJING,
CN
100015
|
|
Applicant Contact |
ZHANG XIAOSONG |
Correspondent |
BEIJING TOPLASER TECHNOLOGY CO., LTD. |
EAST 3RD FL, BLDG M7 |
# 1 JIUXIANQIAO EAST RD |
CHAOYANG DISTRICT, BEIJING,
CN
100015
|
|
Correspondent Contact |
ZHANG XIAOSONG |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/24/2013 |
Decision Date | 01/23/2014 |
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
|
|
|