510(k) Report

FDA applicant

Eleme Medical, Inc.

Merrimack, NH3 decisions2009–20100 recalls

FDA records 3 decisions for Eleme Medical, Inc. (Merrimack, NH) from 2009 to 2010: 3 510(k) clearances. Most are in product codes NUV (Massager, Vacuum, Light Induced Heating) and 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 Eleme Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 22010: 1
2009high 2 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Eleme Medical, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eleme Medical, 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?

  • NUVMassager, Vacuum, Light Induced Heating2decisions
  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K083629SmoothshapesEleme Medical, Inc. · 20091cites it
  • K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc. · 20101cites it

What has FDA decided for it lately?

  • K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc. · 2010
  • K083478SmoothlipoEleme Medical, Inc. · 2009
  • K083629SmoothshapesEleme Medical, Inc. · 2009

All 3 as Eleme Medical, Inc. →