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
-
-