FDA 510(k) Application Details - K151516

Device Classification Name Laser, Comb, Hair

  More FDA Info for this Device
510(K) Number K151516
Device Name Laser, Comb, Hair
Applicant Capillus, LLC
1715 NW 82ND AVENUE
MIAMI, FL 33126 US
Other 510(k) Applications for this Company
Contact PATRICIA SCHNOOR
Other 510(k) Applications for this Contact
Regulation Number 890.5500

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

  More FDA Info for this Product Code
Date Received 06/05/2015
Decision Date 08/21/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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