510(k) Report

FDA applicant

Palomar

Cary, NC2 decisions2001–20020 recalls

FDA records 2 decisions for Palomar (Cary, NC) from 2001 to 2002: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Palomar’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Palomar since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Palomar by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument2decisions

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K020941Palomar Luxg HandpiecePalomar · 20026cite it
  • K010618Palomar Dermalux Pulsed Light SystemPalomar · 20011cites it

What has FDA decided for it lately?

  • K020941Palomar Luxg HandpiecePalomar · 2002
  • K010618Palomar Dermalux Pulsed Light SystemPalomar · 2001

All 2 as Palomar →

Other applicant names beginning “Palomar”

FDA records each applicant name separately; these may or may not be the same firm.

Palomar Medical Technologies, Inc. 24Palomar Medical Products, Inc. 21