The following data is part of a premarket notification filed by Shenzhen Noble Smart Manufacturing Tech Co. Ltd with the FDA for Ipl Hair Removal Device.
| Device ID | K222598 |
| 510k Number | K222598 |
| Device Name: | IPL Hair Removal Device |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Noble Smart Manufacturing Tech Co. Ltd 3F, Building A, Zhengchangda Technology Park, Jian'an, Fuhai Town, Bao'an District Shenzhen, CN 518103 |
| Contact | Guo Yi |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming 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 | 2022-08-29 |
| Decision Date | 2022-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06975526410005 | K222598 | 000 |