Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K895518 |
Device Name |
COHERENT HOLMIUM:YAG SURGICAL LASER |
Applicant |
LUMENIS, INC. |
3270 WEST BAYSHORE RD. |
POST OFFICE BOX 10122 |
PALO ALTO,
CA
94303 -0810
|
|
Applicant Contact |
VIRGINIA SINGER |
Correspondent |
LUMENIS, INC. |
3270 WEST BAYSHORE RD. |
POST OFFICE BOX 10122 |
PALO ALTO,
CA
94303 -0810
|
|
Correspondent Contact |
VIRGINIA SINGER |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/12/1989 |
Decision Date | 11/30/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|