The following data is part of a premarket notification filed by Jiangsu Unimed Laser Technology Co., Ltd. with the FDA for Advanced Skin Renewing Device.
| Device ID | K182498 |
| 510k Number | K182498 |
| Device Name: | Advanced Skin Renewing Device |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | Jiangsu Unimed Laser Technology Co., Ltd. 2F, Building D4, No.6, West Dongsheng Road, High-tech District Jiangyin, CN 214000 |
| Contact | Simon Wang |
| Correspondent | Simon Wang Jiangsu Unimed Laser Technology Co., Ltd. 2F, Building D4, No.6, West Dongsheng Road, High-tech District Jiangyin, CN 214000 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-12 |
| Decision Date | 2018-11-30 |