510(k) Report

FDA applicant

Classy Lady by Mehl of Puerto Rico, Inc.

Budd Lake, NJ1 decision1997–19970 recalls

FDA records 1 decision for Classy Lady by Mehl of Puerto Rico, Inc. (Budd Lake, NJ) in 1997: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 2 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 Classy Lady by Mehl of Puerto Rico, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Classy Lady by Mehl of Puerto Rico, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Classy Lady by Mehl of Puerto Rico, 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 Instrument1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K962109SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair RemovalClassy Lady by Mehl of Puerto Rico, Inc. · 19973cite it

What has FDA decided for it lately?

  • K962109SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair RemovalClassy Lady by Mehl of Puerto Rico, Inc. · 1997

The one decision as Classy Lady by Mehl of Puerto Rico, Inc. →