SCULPTURE— 510(k) K971609

Name: FDA 510(k) clearance K971609
Creator: U.S. Food and Drug Administration
Published: 1997-08-14

Substantially Equivalent

Servizi Medico Estetici Italinai Srl.

FDA 510(k) clearance K971609 for SCULPTURE, Substantially Equivalent on 1997-08-14. Applicant: Servizi Medico Estetici Italinai Srl.. Device class: Unclassified.

Clearance details

Applicant: Servizi Medico Estetici Italinai Srl.
Product code: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 1997-05-01
Decision date: 1997-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Casale Monferrato (Al), IT

Download summary PDF View on FDA.gov ↗

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K980301 — IP-161998-03-24

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.