SKINTACT AND VARIOUS OTHER TRADENAMES— 510(k) K073104

Name: FDA 510(k) clearance K073104
Creator: U.S. Food and Drug Administration
Published: 2007-11-16

Substantially Equivalent

Leonhard Lang GmbH

FDA 510(k) clearance K073104 for SKINTACT AND VARIOUS OTHER TRADENAMES, Substantially Equivalent on 2007-11-16. Applicant: Leonhard Lang GmbH. Device class: 2.

Clearance details

Applicant: Leonhard Lang GmbH
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 2007-11-02
Decision date: 2007-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Stillwater, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Leonhard Lang GmbH

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K142803 — Skintact, various other tradenames2014-12-02
K140500 — SKINTACT2014-07-29
K140340 — SKINTACT2014-05-21
K103186 — SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES2011-02-08
K092291 — SKINTACT AND VARIOUS OTHER TRADENAMES2009-08-21

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.