Palomar SLP 1000

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

510(k) Number

K010580 ↗

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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See all devices from Palomar Medical Technologies, Inc. →

• What is the Palomar SLP 1000 used for?

  The Palomar SLP 1000 is a diode laser system that delivers 810 nm infrared light for the treatment of pseudofolliculitis barbae, hair removal, permanent hair reduction, and treatment of pigmented and vascular lesions including facial and leg veins.

• What components are included with the Palomar SLP 1000 system?

  The system consists of a power unit, chiller, footswitch, and a water-cooled handpiece. It is supplied as a complete system with various components and is intended for use in clinical settings.

• Is the Palomar SLP 1000 single-use or reusable?

  The device is not specified as single-use or reusable in the provided data. The system is designed for clinical use, but the specific reusability of individual components is not detailed in the information provided.

• What regulatory approval has the Palomar SLP 1000 received?

  The Palomar SLP 1000 has received FDA 510(k) clearance with product code GEX and was determined to be substantially equivalent. It was reviewed by the General and Plastic Surgery advisory committee.