FDA 510(k) Application Details - K242619

Device Classification Name Laser, Comb, Hair

  More FDA Info for this Device
510(K) Number K242619
Device Name Laser, Comb, Hair
Applicant Apira Science Inc
409 Edmon Rd. NE Suite C
Albuquerque, NM 87107 US
Other 510(k) Applications for this Company
Contact Ray Pizinger
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 09/03/2024
Decision Date 12/02/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242619


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