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

Ocular Pattern Recorder

21 CFR 886.1925 / Ophthalmic
FDA source (opens on fda.gov)

PLZ is the FDA product code for Ocular Pattern Recorder, a class II device type, regulated under 21 CFR 886.1925. FDA's definition for this code 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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PLZ
Device name
Ocular Pattern Recorder
FDA 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.
Regulation
21 CFR 886.1925
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PLZ

By decision year
1 clearance under product code PLZ with a decision year between 2016 and 2016, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PLZ by decision year
YearClearances
20161

Applicants with the most clearances

Product code PLZ
Applicants holding the most 510(k) clearances under product code PLZ
ApplicantClearances
Sensimed SA1

Companies listing this code with FDA

Companies whose registered establishments list this code