Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K973470 |
Device Name |
COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS |
Applicant |
LUMENIS, INC. |
3270 WEST BAYSHORE RD. |
POST OFFICE BOX 10122 |
PALO ALTO,
CA
94303 -0810
|
|
Applicant Contact |
KAREN BAKER |
Correspondent |
LUMENIS, INC. |
3270 WEST BAYSHORE RD. |
POST OFFICE BOX 10122 |
PALO ALTO,
CA
94303 -0810
|
|
Correspondent Contact |
KAREN BAKER |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/12/1997 |
Decision Date | 12/09/1997 |
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
|