510(k) Report

FDA applicant

Acculaser, Inc.

Chevy Chase, MD2 decisions2002–20040 recalls

FDA records 2 decisions for Acculaser, Inc. (Chevy Chase, MD) from 2002 to 2004: 2 510(k) clearances. All are in product code NHN (Powered Light Based Laser Non-Thermal…). Its devices cite 3 predicates, 1 of them its own earlier devices. 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, physical medicine panel, where it files most

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

FDA decisions per year

No FDA decision for Acculaser, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Acculaser, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive…2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K020657Acculaser Pro Low Level Laser Therapy DeviceAcculaser, Inc. · 20025cite it
  • K023060Acculaser PRO4Acculaser, Inc. · 20041cites it

What has FDA decided for it lately?

  • K023060Acculaser PRO4Acculaser, Inc. · 2004
  • K020657Acculaser Pro Low Level Laser Therapy DeviceAcculaser, Inc. · 2002

All 2 as Acculaser, Inc. →