TargetCool (RM-DT02W)— 510(k) K253114

Substantially Equivalent

Recensmedical, Inc.

FDA 510(k) clearance K253114 for TargetCool (RM-DT02W), Substantially Equivalent on 2025-10-16. Applicant: Recensmedical, Inc..

Clearance details

Applicant: Recensmedical, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2025-09-24
Decision date: 2025-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

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.