| Device Classification Name |
powered laser surgical instrument
|
|---|
| 510(k) Number |
K103654 |
|---|
| Device Name |
VELA XL |
|---|
| Applicant |
| STARMEDTEC GMBH |
| KREUZSTRASSE 22 |
|
STARNBERG,
DE
82319
|
|
| Applicant Contact |
GREGOR WEIDEMANN |
| Correspondent |
| STARMEDTEC GMBH |
| KREUZSTRASSE 22 |
|
STARNBERG,
DE
82319
|
|
| Correspondent Contact |
GREGOR WEIDEMANN |
| Regulation Number | 878.4810
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 12/15/2010 |
|---|
| Decision Date | 04/06/2011 |
|---|
| 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
|
|---|