# K023734: Aramis II Dermatological Laser

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: May 6, 2003 after 180 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 K820106 (1982). 11 ancestors in all.
317 later devices descend from it; 2 cite it directly.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012545: Aramis Dermatlogic Laser, Lumedics, Ltd. (2001)
- K002649: Aramis Dermatological Laser, Palomar Medical Technologies, Inc. (2000)
- K962791: New Star Model 130 6-Watt ND: Yag Laser System, New Star Lasers, Inc. (1997) Summary page 1.
- K013825: Candela Smoothbeam Laser System, Candela Corp. (2002)
- K003715: Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch, Cooltouch II, Cooltouch Corp. (2001)

## Most influential descendants
- K040617: Reliant Laser System II (2004), 316 descendants of its own
- K042319: Reliant Laser II System and Accessories (2005), 284 descendants of its own
- K061652: Palomar LUX1540 Handpiece (2007), 259 descendants of its own
- K060310: Fraxel II SR Laser System and Accessories (2006), 230 descendants of its own
- K062303: Fraxel II SR Laser System (2007), 226 descendants of its own

## Indications for use
The Aramis I1 Dermatological Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis I1 laser is also indicated for the removal of pigmented lesions; photocoagulation of dermatological vascular lesions, including photothermolysis of blood vessels (treatment of facial and leg veins), and for the treatment of periorbital and perioral wrinkles. The Aramis II Dermatological Laser is also labeled: CAUTION: Federal law restricts the sale to or use by licensed professionals.

Source page: https://510kreport.com/device/K023734
Methodology: https://510kreport.com/methodology