The following data is part of a premarket notification filed by Medical Device Branch Of Zhangzhou Easepal Industrial Co.,lt with the FDA for Ipl Salon Hair Reduction System.
| Device ID | K181568 |
| 510k Number | K181568 |
| Device Name: | IPL Salon Hair Reduction System |
| Classification | Light Based Over-the-counter Hair Removal |
| Applicant | Medical Device Branch Of Zhangzhou Easepal Industrial Co.,Lt 4th Floor Of Building #1, No.228, Jiaosong Road Taiwanese Investment Zone Zhangzhou, CN |
| Contact | Bruce Wu |
| Correspondent | Iris Fung SGS-CSTC Standards Technical Services Co., Ltd. 108 Kezhu Road Scientech Park Guangzhou Economic & Technology Dept Guangzhou, CN |
| Product Code | OHT |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-14 |
| Decision Date | 2018-09-11 |
| Summary: | summary |