New Era— 510(k) K182604

Substantially Equivalent

Step UP Skin Laser, LLC

FDA 510(k) clearance K182604 for New Era, Substantially Equivalent on 2018-11-14. Applicant: Step UP Skin Laser, LLC.

Clearance details

Applicant: Step UP Skin Laser, LLC
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2018-09-21
Decision date: 2018-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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.