TheraFace Mask— 510(k) K230293

Substantially Equivalent

Therabody, Inc.

FDA 510(k) clearance K230293 for TheraFace Mask, Substantially Equivalent on 2023-06-09. Applicant: Therabody, Inc..

Clearance details

Applicant: Therabody, Inc.
Product code: Code OHS
Advisory panel: General, Plastic Surgery
Date received: 2023-02-02
Decision date: 2023-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OHS

product code OHS

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.