Intense Pulsed Light Therapy Device— 510(k) K261204

Name: FDA 510(k) clearance K261204
Creator: U.S. Food and Drug Administration
Published: 2026-06-12

Substantially Equivalent

Sanhe LEFIS Electronics Co., Ltd.

FDA 510(k) clearance K261204 for Intense Pulsed Light Therapy Device, Substantially Equivalent on 2026-06-12. Applicant: Sanhe LEFIS Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sanhe LEFIS Electronics Co., Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2026-04-13
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langfang, CN

Download summary PDF View on FDA.gov ↗

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K250281 — DEKA LOTUS2025-02-26
K242440 — Intense Pulsed Light Treatment System (LK-PT)2024-11-14

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