Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K133319 |
Device Name |
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 |
Applicant |
LUMENIS LTD. |
6 HAKIDMA STREET, YOKNEAM INDUSTRIAL PARK |
P.O. BOX 240 |
YOKNEAM,
IL
2069204
|
|
Applicant Contact |
IMAN KHORSHID |
Correspondent |
Boston Scientific |
100 Boston Scientific Way |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Donn M Gardner |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 10/28/2013 |
Decision Date | 03/20/2014 |
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
|