FDA 510(k) Application Details - K203510

Device Classification Name Light Based Over-The-Counter Hair Removal

  More FDA Info for this Device
510(K) Number K203510
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Weikai Technology CO.,LTD
FL402, Building A, No.466 Jinbi Road, Biling Community,
Biling Street, Pingshan District
Shenzhen 518118 CN
Other 510(k) Applications for this Company
Contact Jing Li
Other 510(k) Applications for this Contact
Regulation Number 878.4810

  More FDA Info for this Regulation Number
Classification Product Code OHT
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 11/30/2020
Decision Date 02/26/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact