Palomar Aspire Laser Platform

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K080567 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Palomar Aspire Laser Platform

  Class II

  FDA 510(k) K081416 Active Cleared 29 May 2008

• Lightsheer Long Pulse Ruby Laser

  Class II

  FDA 510(k) K982980 Active Cleared 4 Mar 1999

• Palomar Starlux Pulsed Light System

  Class II

  FDA 510(k) K041086 Active Cleared 13 Jan 2005

• Modification to LUX1540 Handpiece and Lux 1440 Handpiece

  Class II

  FDA 510(k) K091446 Active Cleared 27 Oct 2009

• Erbium Fractional Handpiece

  Class II

  FDA 510(k) K083900 Active Cleared 27 Feb 2009

• Palomar Lux 1540 Handpiece

  Class II

  FDA 510(k) K080244 Active Cleared 20 Jun 2008

See all devices from Palomar Medical Products, Inc. →

• What types of clinical settings can the Palomar Aspire Laser Platform be used in, and why is this important?

  The Palomar Aspire Laser Platform is designed for use in surgical settings such as operating rooms and outpatient clinics. This is important because it ensures controlled environments where clinical supervision and sterile procedures are standard, aligning with the device’s intended use for non-surgical fat reduction via laser-assisted lipolysis. Its compatibility with MRI environments, as noted by the manufacturer, also expands its utility in facilities where imaging is routinely performed.

• Is the Palomar Aspire Laser Platform intended for single-use or reusable applications, and what does this mean for maintenance?

  The Palomar Aspire Laser Platform is a reusable medical device, meaning it is designed for repeated use in clinical settings. This requires strict adherence to manufacturer guidelines for sterilization and maintenance to ensure safety, functionality, and compliance with regulatory standards. Proper cleaning and sterilization protocols are essential to prevent contamination and preserve device integrity between procedures.

• How is the Palomar Aspire Laser Platform regulated, and what does this classification mean for clinicians?

  The Palomar Aspire Laser Platform is regulated under the FDA’s 510(k) clearance pathway (K080567) and classified as a General, Plastic Surgery device under the Plastic Surgery Advisory Committee. This classification indicates that the device is intended for use in plastic surgery procedures, specifically non-surgical fat reduction, and has been deemed substantially equivalent to a legally marketed predicate device. Clinicians should confirm the device’s compatibility with their facility’s protocols and ensure it is used as intended within approved surgical settings.

• What components make up the Palomar Aspire Laser Platform, and how do they work together?

  The Palomar Aspire Laser Platform consists of a handheld handpiece, a control console, and associated accessories. These components work together to deliver precise laser energy for selective targeting and breakdown of adipose tissue, facilitating fat removal either through liposuction or natural absorption. The handheld device applies the energy directly to the patient, while the console controls parameters like energy settings, ensuring clinical precision under direct supervision.

• Why is it important to follow sterile protocols when storing and handling the Palomar Aspire Laser Platform?

  The Palomar Aspire Laser Platform is a reusable device intended for invasive procedures, so maintaining sterility is critical to prevent infections and ensure patient safety. Sterile storage and handling protocols protect both the device and the patient, as contamination could compromise the device’s functionality or lead to adverse clinical outcomes. Adhering to these guidelines also supports regulatory compliance and maintains the device’s performance over repeated uses.