510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111341Substantially Equivalent

Cleane / Cleane Pop

Medicon Co., Ltd., Fullerton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111341 is the FDA 510(k) clearance record for CLEANE / CLEANE POP, a class II device, cleared for Medicon Co., Ltd. on under FDA product code OZC (Over The Counter Thermal Treatment For Acne.). FDA's definition for product code OZC reads: "For the treatment of mild to moderate inflammatory acne". FDA records list 15 510(k) clearances for Medicon Co., Ltd., from to . As of , FDA records show no recalls naming K111341.

Clearance record

Decision date
Received
(293 days to decision)
Product code
OZC Over The Counter Thermal Treatment For Acne.
Regulation
21 CFR 890.5740
Device class
Class II
Review panel
Physical Medicine
Applicant
Medicon Co., Ltd. 951 St.Arbuck St., Fullerton CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZC

Trailing 12 months

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

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