510(k) Report

FDA applicant

Optomedic Medical Technologies, Ltd.

Rockville, MD2 decisions1995–19980 recalls

FDA records 2 decisions for Optomedic Medical Technologies, Ltd. (Rockville, MD) from 1995 to 1998: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 6 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, general and plastic surgery panel, where it files most

How often FDA has decided Optomedic Medical Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Optomedic Medical Technologies, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Optomedic Medical Technologies, Ltd. 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 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K950313Kaplan Pendulaser 115 - a 15W CO2 Surgical LaserOptomedic Medical Technologies, Ltd. · 19951cites it

What has FDA decided for it lately?

  • K980398Kaplan Pendulaser 115 Surgical Laser with Optoscan IIOptomedic Medical Technologies, Ltd. · 1998
  • K950313Kaplan Pendulaser 115 - a 15W CO2 Surgical LaserOptomedic Medical Technologies, Ltd. · 1995

All 2 as Optomedic Medical Technologies, Ltd. →