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 |