Palomar SLP 1000

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

510(k) Number

K013028 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K982980 Active Cleared 4 Mar 1999

• Palomar Starlux Pulsed Light System

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  FDA 510(k) K041086 Active Cleared 13 Jan 2005

• Modification to LUX1540 Handpiece and Lux 1440 Handpiece

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• Erbium Fractional Handpiece

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  FDA 510(k) K083900 Active Cleared 27 Feb 2009

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  FDA 510(k) K080244 Active Cleared 20 Jun 2008

See all devices from Palomar Medical Products, Inc. →

• What clinical applications is the Palomar SLP 1000 intended for?

  The system is designed for dermatologic and cosmetic procedures, specifically pseudofolliculitis barbae, hair removal and permanent hair reduction, and the treatment of pigmented and vascular lesions such as facial and leg veins. These uses align with its 810 nm infrared output and FDA 510(k) clearance for general and plastic surgery.

• What components are included when the device is supplied?

  Each Palomar SLP 1000 unit is delivered as a complete system comprising a power unit, a chiller to maintain handpiece temperature, a footswitch for hands‑free operation, and a water‑cooled handpiece that emits the laser energy. This package ensures the clinician has all necessary hardware for immediate use in a controlled setting.

• Is the Palomar SLP 1000 a sterile or single‑use device?

  The device is not described as sterile nor as single‑use. It is a reusable powered laser instrument intended for clinical use in a controlled environment, requiring the user to follow standard cleaning and maintenance procedures rather than discarding it after one procedure.

• What regulatory pathway was used for the Palomar SLP 1000?

  The system was cleared through the FDA 510(k) process (K013028) as a powered laser surgical instrument. It was found substantially equivalent to a predicate device and classified under product code GEX for general and plastic surgery applications.