Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K083258 |
Device Name |
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE |
Applicant |
DORNIER MEDTECH AMERICA, INC. |
1155 ROBERTS BLVD. |
KENNESAW,
GA
30144
|
|
Applicant Contact |
THERON GOBER |
Correspondent |
DORNIER MEDTECH AMERICA, INC. |
1155 ROBERTS BLVD. |
KENNESAW,
GA
30144
|
|
Correspondent Contact |
THERON GOBER |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/04/2008 |
Decision Date | 01/30/2009 |
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
|
|
|