510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K232930Substantially Equivalent

Verve

Oculomotor Technologies, Princeton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232930 is the FDA 510(k) clearance record for VERVE, a class I device, cleared for Oculomotor Technologies on under FDA product code SBN (Digital Therapy Device For Convergence Insufficiency). FDA's definition for product code SBN reads: "A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency". FDA records list one 510(k) clearance for Oculomotor Technologies. As of , FDA records show no recalls naming K232930.

Clearance record

Decision date
Received
(267 days to decision)
Product code
SBN Digital Therapy Device For Convergence Insufficiency
Regulation
21 CFR 886.1290
Device class
Class I
Review panel
Ophthalmic
Applicant
Oculomotor Technologies 155 Village Blvd., Suite 130, Princeton NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SBN

Trailing 12 months

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

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