| Device Classification Name |
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
|
|---|
| 510(k) Number |
K093168 |
|---|
| Device Name |
MEDIFLASH AND ESTEFLASH |
|---|
| Applicant |
| DERMEO |
| 1468 Harwell Avenue |
|
Crofton,
MD
21114
|
|
| Applicant Contact |
E.J. Smith |
| Correspondent |
| DERMEO |
| 1468 Harwell Avenue |
|
Crofton,
MD
21114
|
|
| Correspondent Contact |
E.J. Smith |
| Regulation Number | 878.4810
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 10/07/2009 |
|---|
| Decision Date | 05/21/2010 |
|---|
| 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
|
|---|