510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221659Substantially Equivalent

Luminopia One

Luminopia Inc, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221659 is the FDA 510(k) clearance record for Luminopia One, a class II device, cleared for Luminopia, Inc. on under FDA product code QQU (Digital Therapy Device For Amblyopia). FDA's definition for product code QQU reads: "A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia". FDA records list 4 510(k) clearances for Luminopia, Inc., from to . As of , FDA records show no recalls naming K221659.

Clearance record

Decision date
Received
(149 days to decision)
Product code
QQU Digital Therapy Device For Amblyopia
Regulation
21 CFR 886.5500
Device class
Class II
Review panel
Ophthalmic
Applicant
Luminopia, Inc. 955 Massachusetts Ave. #335, Cambridge MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QQU

Trailing 12 months

FDA records hold no clearances under product code QQU in the trailing twelve months.

FDA records show no clearances under product code QQU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QQU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260