Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K043012 |
Device Name |
OMNIPULSE MINI, MODEL 2120 |
Applicant |
TRIMEDYNE, INC. |
15091 BAKE PKWY. |
IRVINE,
CA
92618
|
|
Applicant Contact |
GLENN YEIK |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
1655 SCOTT BLVD. |
SANTA CLARA,
CA
95050
|
|
Correspondent Contact |
ELIZABETH DREW |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/02/2004 |
Decision Date | 11/17/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|