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 |