The following data is part of a premarket notification filed by Shenzhen Beauty Every Moment Intelligent Electric Co.,ltd. with the FDA for Ipl Home Use Hair Removal Device.
| Device ID | K221001 |
| 510k Number | K221001 |
| Device Name: | IPL Home Use Hair Removal Device |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Beauty Every Moment Intelligent Electric Co.,Ltd. Rm.101,201,501, Bldg. 4, Haoer Jiashitai Technology Park, Fengtang Avenue No.164, Zhancheng Co Shenzhen, CN 518100 |
| Contact | Luo Huajun |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group 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 | 2022-04-04 |
| Decision Date | 2022-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974879931984 | K221001 | 000 |
| 06974879931977 | K221001 | 000 |
| 06974879931892 | K221001 | 000 |
| 06974879931861 | K221001 | 000 |
| 06974879931854 | K221001 | 000 |
| 06974879934862 | K221001 | 000 |
| 06974879933865 | K221001 | 000 |
| 06974879932868 | K221001 | 000 |