# K012545: Aramis Dermatlogic Laser

- Pathway: 510(k) (Traditional)
- Applicant: Lumedics, Ltd.
- Decided: Nov 5, 2001 after 90 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
No predicates in its family tree.
318 later devices descend from it; 1 cites it directly.
0 of 319 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Palomar Medical Technologies, Inc. Aramis Dermatologic Laser: named in the summary without a submission number

## Most influential descendants
- K023734: Aramis II Dermatological Laser (2003), 317 descendants of its own
- 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

## Indications for use
The Aramis Dermatologic Laser system is intended to be used for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. The Aramis 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).

Source page: https://510kreport.com/device/K012545
Methodology: https://510kreport.com/methodology