510(k) Report

FDA applicant

Laserlite, LLC

Boston, MA2 decisions1998–19980 recalls

FDA records 2 decisions for Laserlite, LLC (Boston, MA) in 1998: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 1 predicate, 0 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Laserlite, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Laserlite, LLC 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

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K981090Laserlite Diode Surgical LaserLaserlite, LLC · 1998
  • K980142Featherlite Diode LaserLaserlite, LLC · 1998

All 2 as Laserlite, LLC →