PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE— 510(k) K102698

Substantially Equivalent

Ellman Int'L, Inc.

FDA 510(k) clearance K102698 for PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE, Substantially Equivalent on 2011-01-05. Applicant: Ellman Int'L, Inc..

Clearance details

Applicant: Ellman Int'L, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2010-09-20
Decision date: 2011-01-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Oceanside, NY, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.