| Device Classification Name |
Powered Laser Surgical Instrument
|
|---|
| 510(k) Number |
K123293 |
|---|
| Device Name |
PASTELLE Q-SWITCHED ND: YAG LASER |
|---|
| Applicant |
| WON TECHNOLOGY CO., LTD. |
| 24125 85TH AVE. SE |
|
WOODINVILLE,
WA
98072
|
|
| Applicant Contact |
Roberta Hines |
| Correspondent |
| WON TECHNOLOGY CO., LTD. |
| 24125 85TH AVE. SE |
|
WOODINVILLE,
WA
98072
|
|
| Correspondent Contact |
Roberta Hines |
| Regulation Number | 878.4810
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 10/22/2012 |
|---|
| Decision Date | 04/11/2013 |
|---|
| 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
|
|---|