Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System— 510(k) K211975

Name: FDA 510(k) clearance K211975
Creator: U.S. Food and Drug Administration
Published: 2021-11-10

Substantially Equivalent

Caldera Medical, Inc.

FDA 510(k) clearance K211975 for Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System, Substantially Equivalent on 2021-11-10. Applicant: Caldera Medical, Inc.. Device class: 2.

Clearance details

Applicant: Caldera Medical, Inc.
Product code: Code OTN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2021-06-25
Decision date: 2021-11-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Westlake Village, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OTN

product code OTN

Injury: 6,630
Total: 6,630

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.