Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K100415 |
Device Name |
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM |
Applicant |
LUMENIS |
20 HATAAS STR. (POB 124) |
KFAR SABA,
IL
44425
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
LUMENIS |
20 HATAAS STR. (POB 124) |
KFAR SABA,
IL
44425
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/16/2010 |
Decision Date | 04/21/2010 |
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
|
Recalls |
CDRH Recalls
|