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 digital therapy device for amblyopia
510(k) Number K221375
Device Name CureSight-CS100
Applicant
NovaSight Ltd.
1 Hayarden St.
Airport City,  IL 7019801
Applicant Contact Ran Yam
Correspondent
Regulatory Pathways Group, Inc.
340 S. Lemon Ave. #2471
Walnut,  CA  91789
Correspondent Contact Lee Kramm
Regulation Number886.5500
Classification Product Code
QQU  
Date Received05/12/2022
Decision Date 09/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT05185076
Reviewed by Third Party No
Combination Product No
-
-