| Device Classification Name |
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
|
|---|
| 510(k) Number |
K101901 |
|---|
| Device Name |
IPL THERAPY SYSTEM |
|---|
| Applicant |
| Beijing Starlight Science & Technology Development |
| Suite 5d # 19 Ln. 999 |
| Zhongshan No 2 Rd.(S) |
|
Shanghai Shanghai,
CN
200030
|
|
| Applicant Contact |
Diana Hong |
| Correspondent |
| Beijing Starlight Science & Technology Development |
| Suite 5d # 19 Ln. 999 |
| Zhongshan No 2 Rd.(S) |
|
Shanghai Shanghai,
CN
200030
|
|
| Correspondent Contact |
Diana Hong |
| Regulation Number | 878.4810 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/08/2010 |
|---|
| Decision Date | 03/08/2011 |
|---|
| 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
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|