Heager Medical Laser Family (Sabrina/Adolf)— 510(k) K250261

Name: FDA 510(k) clearance K250261
Creator: U.S. Food and Drug Administration
Published: 2025-08-26

Substantially Equivalent

Heager GmbH

FDA 510(k) clearance K250261 for Heager Medical Laser Family (Sabrina/Adolf), Substantially Equivalent on 2025-08-26. Applicant: Heager GmbH. Device class: 2.

Clearance details

Applicant: Heager GmbH
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-01-29
Decision date: 2025-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Haan, DE

Download summary PDF View on FDA.gov ↗

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K261589 — 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)2026-09-02
K262269 — CO2 Laser System (MBT- CO2 Laser)2026-09-01
K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)2026-08-27

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.