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 K221659
Device Name Luminopia One
Applicant
Luminopia, Inc.
955 Massachusetts Ave #335
Cambridge,  MA  02139
Applicant Contact Scott Xiao
Correspondent
Luminopia, Inc.
955 Massachusetts Ave #335
Cambridge,  MA  02139
Correspondent Contact Scott Xiao
Classification Product Code
QQU  
Date Received06/08/2022
Decision Date 11/04/2022
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
-
-