• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name confocal optical imaging
510(k) Number K220477
Device Name Cellvizio 100 series system with confocal Miniprobes
Mauna Kea Technologies
9 Rue d'Enghien
Paris,  FR 75010
Applicant Contact Aline Criton
Daniel & Daniel Consulting
340 Jones Lane
Gardnerville,  NV  89460
Correspondent Contact Michael A. Daniel
Regulation Number876.1500
Classification Product Code
Subsequent Product Codes
Date Received02/18/2022
Decision Date 04/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No