The following data is part of a premarket notification filed by Shenzhen Fansizhe Science And Technology Co., Ltd with the FDA for Intense Pulsed Light (ipl) System.
Device ID | K212881 |
510k Number | K212881 |
Device Name: | Intense Pulsed Light (IPL) System |
Classification | Light Based Over-the-counter Hair Removal |
Applicant | Shenzhen Fansizhe Science And Technology Co., Ltd 2nd And 3rd Floors, No. 17, Xinfa 2nd Road, Xinqiao Community, Xinqiao Street, Baoan District Shenzhen, CN 518125 |
Contact | Cheng Endang |
Correspondent | Jet You Qimmiq Medical Consulting Service Co., Ltd RM. 1711 Building K, NO 101 Science Ave. International Creative Valley Development Zone 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 | 2021-09-10 |
Decision Date | 2022-04-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06971008271034 | K212881 | 000 |