Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K003614 |
Device Name |
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM |
Applicant |
COHERENT STAR |
1249 QUARRY LN. |
SUITE 100 |
PLEASANTON,
CA
94566
|
|
Applicant Contact |
ILIRIJA ENCINAS |
Correspondent |
COHERENT STAR |
1249 QUARRY LN. |
SUITE 100 |
PLEASANTON,
CA
94566
|
|
Correspondent Contact |
ILIRIJA ENCINAS |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/22/2000 |
Decision Date | 03/13/2001 |
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
|
Recalls |
CDRH Recalls
|