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 |