510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220090Substantially Equivalent

Visibly Digital Acuity Product

Visibly, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220090 is the FDA 510(k) clearance record for Visibly Digital Acuity Product, a class I device, cleared for Visibly, Inc. on under FDA product code QTO (Digital Visual Acuity Test). FDA's definition for product code QTO reads: "A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients". FDA records list one 510(k) clearance for Visibly, Inc. As of , FDA records show no recalls naming K220090.

Clearance record

Decision date
Received
(213 days to decision)
Product code
QTO Digital Visual Acuity Test
Regulation
21 CFR 886.1150
Device class
Class I
Review panel
Ophthalmic
Applicant
Visibly, Inc. 207 E Ohio St., #233, Chicago IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QTO

Trailing 12 months

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

FDA records show no clearances under product code QTO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QTO, 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