510(k) Report

FDA applicant

Mehl/Biophile Intl., Inc.

Budd Lake, NJ2 decisions1997–19980 recalls

FDA records 2 decisions for Mehl/Biophile Intl., Inc. (Budd Lake, NJ) from 1997 to 1998: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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 Mehl/Biophile Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mehl/Biophile Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mehl/Biophile Intl., Inc. 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

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K971814Improvements to the Mehl Ruby LaserMehl/Biophile Intl., Inc. · 19972cite it

What has FDA decided for it lately?

  • K980753Chromoscan Scanning SystemMehl/Biophile Intl., Inc. · 1998
  • K971814Improvements to the Mehl Ruby LaserMehl/Biophile Intl., Inc. · 1997

All 2 as Mehl/Biophile Intl., Inc. →

Other applicant names beginning “Mehl/Biophile”

FDA records each applicant name separately; these may or may not be the same firm.

Mehl/Group Marketing 1Mehl, Thomas L. 1