The following data is part of a premarket notification filed by Stetic Medical Aesthetics Development (shenzhen) Co. ,ltd with the FDA for Duo.
| Device ID | K161565 |
| 510k Number | K161565 |
| Device Name: | DUO |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD 10-11th Floor, Bensi Building, New High-Tech-Park, Ganli Village, Buji District Shenzhen, CN |
| Contact | Juan Ye |
| Correspondent | Iris Fung SGS-CSTC Standards Technical Services Co., Ltd. 198 KEZHU Road, SCIENTECH Park Guangzhou Guangzhou, CN |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-06 |
| Decision Date | 2016-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16970821120052 | K161565 | 000 |
| 16970821120045 | K161565 | 000 |
| 06970821120031 | K161565 | 000 |
| 06970821120024 | K161565 | 000 |
| 06970821120017 | K161565 | 000 |