CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED— 510(k) K172049

Substantially Equivalent

Cry IQ AB

FDA 510(k) clearance K172049 for CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED, Substantially Equivalent on 2017-08-30. Applicant: Cry IQ AB.

Clearance details

Applicant: Cry IQ AB
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2017-07-06
Decision date: 2017-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Onsala, SE

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.