miraDry System MD4000— 510(k) K150419

Substantially Equivalent

Miramar Labs, Inc.

FDA 510(k) clearance K150419 for miraDry System MD4000, Substantially Equivalent on 2015-06-19. Applicant: Miramar Labs, Inc..

Clearance details

Applicant: Miramar Labs, Inc.
Product code: Code OUB
Advisory panel: General, Plastic Surgery
Date received: 2015-02-18
Decision date: 2015-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUB

product code OUB

Injury: 215
Total: 215

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.