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 | K211185 |
| 510k Number | K211185 |
| 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. 501, Bldg. 4, Haoer Jiashitai Technology Park, Fengtang Avenue No. 164, Heping Community 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 | 2021-04-20 |
| Decision Date | 2021-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974879931878 | K211185 | 000 |
| 06974879931786 | K211185 | 000 |
| 06974879931717 | K211185 | 000 |
| 06974879931564 | K211185 | 000 |
| 06974879931557 | K211185 | 000 |
| 06974879931533 | K211185 | 000 |
| 06974879931502 | K211185 | 000 |
| 06974879931267 | K211185 | 000 |