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 | K162782 |
| 510k Number | K162782 |
| Device Name: | IHelmet Hair Growth System |
| Classification | Laser, Comb, Hair |
| Applicant | Slinph Technologies Co., LTD Room 211, Building B, 1970 Cultural And Creative Park, Mini Street Shenzhen, CN 518107 |
| Contact | Zou Jian |
| Correspondent | Cecilia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, CN 510663 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-03 |
| Decision Date | 2017-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971008070019 | K162782 | 000 |