# K032260: Aramis II Dermatological Laser

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Nov 20, 2003 after 121 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: 2 generations back to K002421 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014128: Candela Smoothbeam Laser System, Candela Corp. (2002)

## Most influential descendants
- K252561: BTL-754FF (2026), 0 descendants of its own

## Indications for use
The Aramis I1 Dermatological Laser system is intended for the treatment of back acne.

Source page: https://510kreport.com/device/K032260
Methodology: https://510kreport.com/methodology