Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37— 510(k) K170111

Name: FDA 510(k) clearance K170111
Creator: U.S. Food and Drug Administration
Published: 2017-05-08

Substantially Equivalent

Pulsaderm, LLC

FDA 510(k) clearance K170111 for Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37, Substantially Equivalent on 2017-05-08. Applicant: Pulsaderm, LLC. Device class: 2.

Clearance details

Applicant: Pulsaderm, LLC
Product code: Code OLP
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2017-01-12
Decision date: 2017-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLP

product code OLP

Other: 1
Total: 1

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.