510(k) K240222— Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)

Substantially Equivalent

Aesthetic Technology, Ltd.

Clearance details

Applicant: Aesthetic Technology, Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2024-01-26
Decision date: 2024-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warrington, GB

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.