Dermatological Diode Laser Systems

Powered Laser Surgical Instrument

Zhuolu Jontelaser Manufacturing Technology Co., Ltd.

The following data is part of a premarket notification filed by Zhuolu Jontelaser Manufacturing Technology Co., Ltd. with the FDA for Dermatological Diode Laser Systems.

Pre-market Notification Details

Device IDK202257
510k NumberK202257
Device Name:Dermatological Diode Laser Systems
ClassificationPowered Laser Surgical Instrument
Applicant Zhuolu Jontelaser Manufacturing Technology Co., Ltd. No. 31, Sanguanmiao Alley, Zhuolu Town, Zhuolu County Zhangjiakou,  CN 072750
ContactKaren Liu
CorrespondentRay Wang
Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHue North Rd., FangShan District Beijing,  CN 102401
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-10
Decision Date2021-04-23

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