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

Eyelid Thermal Pulsation System

21 CFR 886.5200 / Ophthalmic
FDA source (opens on fda.gov)

ORZ is the FDA product code for Eyelid Thermal Pulsation System, a class II device type, regulated under 21 CFR 886.5200. FDA's definition for this code reads: "Therapeutic application of heat and massage to the eyelids". As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
ORZ
Device name
Eyelid Thermal Pulsation System
FDA definition
Therapeutic application of heat and massage to the eyelids.
Regulation
21 CFR 886.5200
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
13
Ingested recalls
3

Clearances, product code ORZ

By decision year
13 clearances under product code ORZ with a decision year between 2011 and 2026, 2011 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ORZ by decision year
YearClearances
20112
20131
20161
20171
20191
20201
20211
20231
20241
20251
20262

Applicants with the most clearances

Product code ORZ
Applicants holding the most 510(k) clearances under product code ORZ
ApplicantClearances
TearScience, Inc.5
Sight Sciences, Inc.4
Tear Film Innovations, Inc.2
Novoxel Inc.1
Sight Sciences, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order