# K081416: Palomar Aspire Laser Platform

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: May 29, 2008 after 9 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: 15 generations back to K943450 (1995). 346 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 356 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080567: Palomar Aspire Laser Platform, Palomar Medical Products, Inc. (2008) Summary page 1.

## Most influential descendants
- K082721: Laserpro 810, 940 and 980 Diode Laser Systems (2008), 7 descendants of its own
- K151890: Medical Diode Laser Systems (2015), 3 descendants of its own
- K252063: Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (2025), 0 descendants of its own
- K243141: Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) (2024), 0 descendants of its own
- K191349: 980nm Diode Laser Therapy Device (2019), 0 descendants of its own

## Indications for use
The Palomar Aspire™ Laser Platform is indicated for laser assisted lipolysis.

Source page: https://510kreport.com/device/K081416
Methodology: https://510kreport.com/methodology