The following data is part of a premarket notification filed by Dongguan Define Beauty Electronic Technology Co. Ltd with the FDA for Ipl Hair Removal.
Device ID | K212318 |
510k Number | K212318 |
Device Name: | IPL Hair Removal |
Classification | Light Based Over-the-counter Hair Removal |
Applicant | Dongguan Define Beauty Electronic Technology Co. Ltd No.10 Xiangya Road, Chicken Wing Ridge Village Dongguan, CN 523821 |
Contact | Shaowu Wang |
Correspondent | Helen Nan Cytech (Shenzhen) Enterprise Management Consulting Co.,Ltd. Room B204, Building 12 Hourui 2nd Industrial Zone, Bao'an District Shezhen, CN 518128 |
Product Code | OHT |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-07-26 |
Decision Date | 2022-01-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IPL HAIR REMOVAL 88693526 not registered Live/Pending |
CUTASSY INC 2019-11-15 |