The following data is part of a premarket notification filed by Wuhan Lotuxs Technology Co., Ltd with the FDA for Silkpro Laser Hair Removal System.
| Device ID | K142845 |
| 510k Number | K142845 |
| Device Name: | SILKPRO Laser Hair Removal System |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Wuhan Lotuxs Technology Co., Ltd No. 666 High-tec Ave. East Lake High-tech Development Zone R&D Building B1 Of B, C, D Block, Wuhan National Biological Wuhan, CN 430075 |
| Contact | Wu Na |
| Correspondent | Wu Na Wuhan Lotuxs Technology Co., Ltd No. 666 High-tec Ave. East Lake High-tech Development Zone R&D Building B1, Of B, C, D Block, Wuhan National Biological Wuhan, CN 430075 |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-07-01 |
| Summary: | summary |