The following data is part of a premarket notification filed by Slinph Technologies Co., Ltd with the FDA for Ihelmet Hair Growth System.
Device ID | K190467 |
510k Number | K190467 |
Device Name: | IHelmet Hair Growth System |
Classification | Laser, Comb, Hair |
Applicant | Slinph Technologies Co., LTD Room 211, Building B, 1970 Cultural And Creative Industrial Park, Mini Street Shenzhen, CN 518107 |
Contact | Zou Jian |
Correspondent | S K SK Medical Device International Corp. Suite 52, Floor 16, No. 119 Xing Guang Ying Jing, Shui Ying Road Guangzhou, CN 51006 |
Product Code | OAP |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-02-26 |
Decision Date | 2019-12-26 |
Summary: | summary |