The following data is part of a premarket notification filed by Yibin Yingtong Intelligent Technology Co.,ltd. with the FDA for Intelligence Lasercomb.
| Device ID | K213789 |
| 510k Number | K213789 |
| Device Name: | Intelligence LaserComb |
| Classification | Laser, Comb, Hair |
| Applicant | Yibin Yingtong Intelligent Technology Co.,Ltd. 3F, Building 1, Area A, Intelligent Terminal Industrial Park Yibin Economic Development Zone Yibin, CN 644000 |
| Contact | Pengcheng Pan |
| Correspondent | Iris Fung SGS-CSTC Standards Technical Services Co., Ltd. 198 Kezhu Road, Scientech Park Guangzhou Economic & Technology Development District Guangzhou, CN 510000 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-06 |
| Decision Date | 2022-06-24 |