XERF— 510(k) K251327

Name: FDA 510(k) clearance K251327
Creator: U.S. Food and Drug Administration
Published: 2025-08-11

Substantially Equivalent

Lutronic Corporation

FDA 510(k) clearance K251327 for XERF, Substantially Equivalent on 2025-08-11. Applicant: Lutronic Corporation. Device class: 2.

Clearance details

Applicant: Lutronic Corporation
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2025-04-30
Decision date: 2025-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deogyang-Gu, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEI

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K254185 — Potenza Prime2026-09-11
K262364 — Ellian Enigma RF Device2026-09-02
K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

More clearances from Lutronic Corporation

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K244060 — eCO2 3D2025-07-31
K213748 — CoreLevee2022-10-14
K213569 — HOLLYWOOD SPECTRA Laser System2022-02-04
K203788 — DermaV Laser System2021-03-26
K183566 — CLARITY II Laser System2019-06-14

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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 →

Recalls naming K251327

K-number listed on FDA's recall record

Z-0146-2026 — XERF EFFECTOR 60. Electrosurgical unit.Class II·Ongoing·Lutronic Corporation·20250904

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K251327.

Data sourced from openFDA. This site is unofficial and independent of the FDA.