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 Device, Analysis, Anterior Segment
510(k) Number K252348
Device Name Tomey Optical Biometer OA-2000 (OA-2000)
Applicant
Tomey Corporation
2-11-33 Noritakeshinmachi Nishiku, Nagoya, Aichi
Nagoya,  JP 4510051
Applicant Contact Yuko Matsushita
Correspondent
Ora, LLC
138 Haverhill St.
Suite 102
Andover,  MA  01810
Correspondent Contact Roger Albright
Regulation Number886.1850
Classification Product Code
MXK  
Date Received07/29/2025
Decision Date 12/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-