Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K142286 |
Device Name |
NS3000 Holmium Laser System |
Applicant |
New Star Lasers, Inc. |
9085 Foothills Blvd. |
Roseville,
CA
95747
|
|
Applicant Contact |
Natalie Vollrath |
Correspondent |
Buckman Company, Inc. |
2800 Pleasant Hill Rd., Suite 175 |
Pleasant Hill,
CA
94523
|
|
Correspondent Contact |
Pamela M. Buckman |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/18/2014 |
Decision Date | 10/31/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|