The following data is part of a premarket notification filed by Shenzhen Ishine Technology Company Limited with the FDA for Ipl Hair Removal Device, Model(s): Skn001,skn005,skn006,skn002,roseskinco Lumi.
| Device ID | K222537 |
| 510k Number | K222537 |
| Device Name: | IPL Hair Removal Device, Model(s): Skn001,skn005,skn006,skn002,RoseSkinCo Lumi |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Ishine Technology Company Limited Room 213 Building 4, No.45, Makan Road, Makan Community, Xili Sub-District,Nanshan District Shenzhen, CN 518055 |
| Contact | Chaohui An |
| Correspondent | Yvonne Liu Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, CN 518052 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-22 |
| Decision Date | 2022-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975773050146 | K222537 | 000 |
| 06975773050139 | K222537 | 000 |
| 06975773050122 | K222537 | 000 |
| 06975773050115 | K222537 | 000 |