The following data is part of a premarket notification filed by Zhuolu Jontelaser Manufacturing Technology Co., Ltd with the FDA for Dermatological Carbon Dioxide Laser Systems.
| Device ID | K202250 |
| 510k Number | K202250 |
| Device Name: | Dermatological Carbon Dioxide Laser Systems |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Zhuolu Jontelaser Manufacturing Technology Co., Ltd No. 31, Sanguanmiao Alley, Zhuolu Town, Zhuolu County Zhangjiakou, CN 072750 |
| Contact | Karen Liu |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-10 |
| Decision Date | 2020-11-25 |