510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872111Substantially Equivalent

Orthotone

Orthotone Corp., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872111 is the FDA 510(k) clearance record for ORTHOTONE, a class II device, cleared for Orthotone Corp. on under FDA product code HLL (Monitor, Eye Movement). FDA records list one 510(k) clearance for Orthotone Corp. As of , FDA records show no recalls naming K872111.

Clearance record

Decision date
Received
(534 days to decision)
Product code
HLL Monitor, Eye Movement
Regulation
21 CFR 886.1510
Device class
Class II
Review panel
Ophthalmic
Applicant
Orthotone Corp. 201 E. 28th St., Suite 6-F, New York NY
Third party review
No

Clearances, product code HLL

Trailing 12 months

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

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