# K111341: Cleane / Cleane Pop

- Pathway: 510(k) (Traditional)
- Applicant: Medicon Co., Ltd.
- Decided: Feb 29, 2012 after 293 days
- Product code: OZC (Over The Counter Thermal Treatment For Acne.)
- Device class: 2
- Regulation: 21 CFR 890.5740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K982082 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043377: ZENO, Tyrell, Inc. (2005) Summary page 1.

## Indications for use
The CLEANE and the CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K111341
Methodology: https://510kreport.com/methodology