The following data is part of a premarket notification filed by Shenzhen Gsd Tech Co., Ltd with the FDA for Light Based Hair Removal Device.
Device ID | K180383 |
510k Number | K180383 |
Device Name: | Light Based Hair Removal Device |
Classification | Light Based Over-the-counter Hair Removal |
Applicant | Shenzhen GSD Tech Co., Ltd Building A Junsd Hi-Tech Park, West Of Bao'an Rd Watch & Clock Base, Guangming District Shenzhen, CN 518106 |
Contact | Ziyi Gui |
Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road, S Shenzhen, CN 518000 |
Product Code | OHT |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-02-12 |
Decision Date | 2018-05-11 |
Summary: | summary |