Intense Pulsed Light (IPL) System

Light Based Over-the-counter Hair Removal

Shenzhen Fansizhe Science And Technology Co., Ltd

The following data is part of a premarket notification filed by Shenzhen Fansizhe Science And Technology Co., Ltd with the FDA for Intense Pulsed Light (ipl) System.

Pre-market Notification Details

Device IDK212881
510k NumberK212881
Device Name:Intense Pulsed Light (IPL) System
ClassificationLight Based Over-the-counter Hair Removal
Applicant Shenzhen Fansizhe Science And Technology Co., Ltd 2nd And 3rd Floors, No. 17, Xinfa 2nd Road, Xinqiao Community, Xinqiao Street, Baoan District Shenzhen,  CN 518125
ContactCheng Endang
CorrespondentJet You
Qimmiq Medical Consulting Service Co., Ltd RM. 1711 Building K, NO 101 Science Ave. International Creative Valley Development Zone Guangzhou,  CN
Product CodeOHT  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-10
Decision Date2022-04-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06971008271034 K212881 000

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