MIRADRY SYSTEM— 510(k) K131162

Substantially Equivalent

Miramar Labs, Inc.

FDA 510(k) clearance K131162 for MIRADRY SYSTEM, Substantially Equivalent on 2013-10-25. Applicant: Miramar Labs, Inc..

Clearance details

Applicant: Miramar Labs, Inc.
Product code: Code OUB
Advisory panel: General, Plastic Surgery
Date received: 2013-04-24
Decision date: 2013-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, 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.