# K032514: AC Applicator, Aurora AC

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Jan 27, 2004 after 166 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 9 generations back to K943450 (1995). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031993: Aurora SR, Syneron Medical, Ltd. (2003) Summary page 1.
- K013623: Clearlight Phototheraphy System, Model CL 420, Curelight, Ltd. (2002) Summary page 1.
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 1.
- K014128: Candela Smoothbeam Laser System, Candela Corp. (2002) Summary page 1.

## Most influential descendants
- K113868: Eplus Skin Treatment System (2012), 0 descendants of its own

## Indications for use
The AC applicator indicated for the treatment of moderate inflammatory acne vulgaries.

Source page: https://510kreport.com/device/K032514
Methodology: https://510kreport.com/methodology