The following data is part of a premarket notification filed by Shenzhen Qianyu Technology Co., Ltd. with the FDA for Hand-held Ipl Device(jovs Graphene Hair Removal Device).
| Device ID | K214113 |
| 510k Number | K214113 |
| Device Name: | Hand-held IPL Device(JOVS Graphene Hair Removal Device) |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Shenzhen Qianyu Technology Co., Ltd. Room 1002, Building A2, KeXing Science Park, No.15 Keyuan Road, Nanshan District Shenzhen, CN 518057 |
| Contact | Kunming Lin |
| Correspondent | Klem Hou Guangzhou Tianke Testing Technology Service Co., Ltd. Room 106-1, 1st Floor, Building A, No. 1, Xin'an Road Yonghe Economic Zone, Huangpu District Guangzhou, CN 510000 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-30 |
| Decision Date | 2022-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973698659208 | K214113 | 000 |
| 06973698650779 | K214113 | 000 |
| 06973698652018 | K214113 | 000 |