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

Over The Counter Thermal Treatment For Acne.

21 CFR 890.5740 / Physical Medicine
FDA source (opens on fda.gov)

OZC is the FDA product code for Over The Counter Thermal Treatment For Acne., a class II device type, regulated under 21 CFR 890.5740. FDA's definition for this code reads: "For the treatment of mild to moderate inflammatory acne". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OZC
Device name
Over The Counter Thermal Treatment For Acne.
FDA definition
For the treatment of mild to moderate inflammatory acne.
Regulation
21 CFR 890.5740
Device class
Class II
Review panel
Physical Medicine
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 OZC

By decision year
1 clearance under product code OZC with a decision year between 2012 and 2012, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OZC by decision year
YearClearances
20121

Applicants with the most clearances

Product code OZC
Applicants holding the most 510(k) clearances under product code OZC
ApplicantClearances
Medicon Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code