Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K153283
Device Name VivoSight Dx Topical OCT System
Applicant
Michelson Diagnostics, Ltd.
Ground Floor Eclipse House, Eclipse Park, Sittingbourne Rd.
Maidstone,  GB me14 3en
Applicant Contact Martin Johns
Correspondent
Michelson Diagnostics, Ltd.
Ground Floor Eclipse House, Eclipse Park, Sittingbourne Rd.
Maidstone,  GB me14 3en
Correspondent Contact Martin Johns
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received11/12/2015
Decision Date 08/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-