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 Ophthalmoscope, Laser, Scanning
510(k) Number K261255
Device Name KOWA FM-600
Applicant
Kowa Company, Ltd. Chofu Factory
3-1 Chofugaoka 3-Chome
Chofu
Tokyo,  JP 182-0021
Applicant Contact Kazunori Matsumura
Correspondent
Ken Block Consulting Co., Ltd.
1-9-9 Hosokawatsukiji Bldg., Tsukiji
Cyuo-Ku
Tokyo,  JP 104-0045
Correspondent Contact Nana Nagashita
Regulation Number886.1570
Classification Product Code
MYC  
Date Received04/16/2026
Decision Date 09/11/2026
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
-
-