IHelmet Hair Growth System

Laser, Comb, Hair

Slinph Technologies Co., LTD

The following data is part of a premarket notification filed by Slinph Technologies Co., Ltd with the FDA for Ihelmet Hair Growth System.

Pre-market Notification Details

Device IDK190467
510k NumberK190467
Device Name:IHelmet Hair Growth System
ClassificationLaser, Comb, Hair
Applicant Slinph Technologies Co., LTD Room 211, Building B, 1970 Cultural And Creative Industrial Park, Mini Street Shenzhen,  CN 518107
ContactZou Jian
CorrespondentS K
SK Medical Device International Corp. Suite 52, Floor 16, No. 119 Xing Guang Ying Jing, Shui Ying Road Guangzhou,  CN 51006
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-26
Decision Date2019-12-26
Summary:summary

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