510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN140017Unknown

Sensimed Triggerfish

Sensimed SA, Waltham MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN140017 is the FDA 510(k) clearance record for SENSIMED TRIGGERFISH, a class II device, cleared for Sensimed AG on under FDA product code PLZ (Ocular Pattern Recorder). FDA's definition for product code PLZ reads: "A diurnal pattern recorder system is a non-implantable, prescription device incorporating a telemetric sensor intended to detect changes in ocular dimension for monitoring diurnal patterns of IOP fluctuation". FDA records list one 510(k) clearance for Sensimed AG. As of , FDA records show no recalls naming DEN140017.

Clearance record

Decision date
Received
(668 days to decision)
Product code
PLZ Ocular Pattern Recorder
Regulation
21 CFR 886.1925
Device class
Class II
Review panel
Ophthalmic
Applicant
Sensimed AG 16 Appleton St., Waltham MA
Third party review
No

Clearances, product code PLZ

Trailing 12 months

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

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