# K080567: Palomar Aspire Laser Platform

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Apr 16, 2008 after 47 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: 14 generations back to K943450 (1995). 345 ancestors in all.
10 later devices descend from it; 3 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)
- K080121: Cynosure Smartlipo Multiwavlength Laser, Cynosure, Inc. (2008) Summary page 1.
- K073394: Smartlipo Laser, Cynosure, Inc. (2007)
- K062321: Smartlipo ND:Yag Laser, Cynosure, Inc. (2006) Summary page 1.
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 1.
- K070388: Profile Multi-Platform System, Sciton, Inc (2007) Summary page 1.
- K072751: Cooltouch Models NS 160 and LC215 Coolipo, New Star Lasers, Inc. (2008) Summary page 1.

## Most influential descendants
- K081416: Palomar Aspire Laser Platform (2008), 9 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K080567
Methodology: https://510kreport.com/methodology