# K111937: Clearflash AC2100 Cosmetic System

- Pathway: 510(k) (Traditional)
- Applicant: Clearflash Technologies, Inc.
- Decided: Feb 8, 2012 after 215 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K982082 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060653: Thermaclear, Dermacare, Inc. (2006) Summary page 1.
- K043377: ZENO, Tyrell, Inc. (2005) Summary page 1.
- K060411: Radiancy Cleartouch Lite Acne Clearance System, Radiancy (Israel), Ltd. (2006) Summary page 1.

## Indications for use
The ClearFlash AC2100 Cosmetic System is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K111937
Methodology: https://510kreport.com/methodology