510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822415Substantially Equivalent

The Ocuplot D

Coherent Medical Division, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822415 is the FDA 510(k) clearance record for THE OCUPLOT D, a class II device, cleared for Coherent Medical Division on under FDA product code HPJ (Instrument, Visual Field, Laser). FDA records list 6 510(k) clearances for Coherent Medical Division, from to . As of , FDA records show no recalls naming K822415.

Clearance record

Decision date
Received
(27 days to decision)
Product code
HPJ Instrument, Visual Field, Laser
Regulation
21 CFR 886.1360
Device class
Class II
Review panel
Ophthalmic
Applicant
Coherent Medical Division 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HPJ

Trailing 12 months

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

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