Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K092964 |
Device Name |
COOLTOUCH VARIA ND:YAG LASER SYSTEM |
Applicant |
NEW STAR LASERS, INC. |
9085 FOOTHILLS BLVD. |
ROSEVILLE,
CA
95747
|
|
Applicant Contact |
NATALIE R VOLLRATH |
Correspondent |
NEW STAR LASERS, INC. |
9085 FOOTHILLS BLVD. |
ROSEVILLE,
CA
95747
|
|
Correspondent Contact |
NATALIE R VOLLRATH |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/25/2009 |
Decision Date | 12/11/2009 |
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
|