R2 Dermal Cooling System— 510(k) K161480

Substantially Equivalent

R2 Dermatology

FDA 510(k) clearance K161480 for R2 Dermal Cooling System, Substantially Equivalent on 2016-10-05. Applicant: R2 Dermatology.

Clearance details

Applicant: R2 Dermatology
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2016-05-31
Decision date: 2016-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.