IPL Salon Hair Reduction System

Light Based Over-the-counter Hair Removal

Medical Device Branch Of Zhangzhou Easepal Industrial Co.,Lt

The following data is part of a premarket notification filed by Medical Device Branch Of Zhangzhou Easepal Industrial Co.,lt with the FDA for Ipl Salon Hair Reduction System.

Pre-market Notification Details

Device IDK181568
510k NumberK181568
Device Name:IPL Salon Hair Reduction System
ClassificationLight Based Over-the-counter Hair Removal
Applicant Medical Device Branch Of Zhangzhou Easepal Industrial Co.,Lt 4th Floor Of Building #1, No.228, Jiaosong Road Taiwanese Investment Zone Zhangzhou,  CN
ContactBruce Wu
CorrespondentIris Fung
SGS-CSTC Standards Technical Services Co., Ltd. 108 Kezhu Road Scientech Park Guangzhou Economic & Technology Dept Guangzhou,  CN
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-14
Decision Date2018-09-11
Summary:summary

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