The following data is part of a premarket notification filed by Shenzhen Bosidin Technology Co., Ltd. with the FDA for Ipl Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130.
| Device ID | K192432 |
| 510k Number | K192432 |
| Device Name: | IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Bosidin Technology Co., Ltd. Rm. 101 & 201, Bldg. 4, Haoer Jiashitai Technology Park Fengtang Avenue Shenzhen, CN 518000 |
| Contact | Wang Jiaoyan |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg. 1, Southward Ruifeng Business Center Guimiao Road 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 | 2019-09-05 |
| Decision Date | 2019-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970112301309 | K192432 | 000 |
| 06970112301293 | K192432 | 000 |
| 06970112301286 | K192432 | 000 |
| 06970112301194 | K192432 | 000 |
| 06970112301033 | K192432 | 000 |