DeviceClearance

Product code PLZ— Ophthalmic

SENSIMED TRIGGERFISH

Classification name
Ocular Pattern Recorder
Device class
Class 2
Regulation
21 CFR 886.1925
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code PLZ under 21 CFR 886.1925, via openFDA

Market context for product code PLZ

FDA has cleared 1 device under product code PLZ, all in 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PLZ

Recent clearances under product code PLZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.