510(k) Report

FDA applicant

Nomir Medical Technologies, Inc.

Waltham, MA2 decisions2007–20080 recalls

FDA records 2 decisions for Nomir Medical Technologies, Inc. (Waltham, MA) from 2007 to 2008: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 7 predicates, 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 Nomir Medical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Nomir Medical Technologies, 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?

  • GEXPowered Laser Surgical Instrument2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K083476Noveon Model LS1100-03Nomir Medical Technologies, Inc. · 2008
  • K071815Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc. · 2007

All 2 as Nomir Medical Technologies, Inc. →