The following data is part of a premarket notification filed by Shenzhen Weikai Technology Co.,ltd with the FDA for Ipl Hair Removal.
| Device ID | K203510 |
| 510k Number | K203510 |
| Device Name: | IPL Hair Removal |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Weikai Technology CO.,LTD FL402, Building A, No.466 Jinbi Road, Biling Community, Biling Street, Pingshan District Shenzhen, CN 518118 |
| Contact | Jing Li |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm2401, ZhenYe International Center, No.3101-90 Qianhai Road, Nanshan District 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 | 2020-11-30 |
| Decision Date | 2021-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970527070074 | K203510 | 000 |
| 06970527070050 | K203510 | 000 |
| 06970527070036 | K203510 | 000 |
| 06970527070012 | K203510 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IPL HAIR REMOVAL 88693526 not registered Live/Pending |
CUTASSY INC 2019-11-15 |