Intense Pulsed Light Therapy Device— 510(k) K261204
Substantially EquivalentSanhe 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.
Summary
Sanhe LEFIS Electronics' Intense Pulsed Light Therapy Device is filed under ONF, powered light-based non-laser surgical instruments with thermal effect. The name is generic, and the record gives no model numbers.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
LEFIS filed from Langfang, China. Review took 60 calendar days (April 13 to June 12, 2026).
Clearance details
- Applicant
- Sanhe LEFIS Electronics Co., Ltd.
- Product code
- Product code ONF
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Langfang, CN
Recent devices under product code ONF
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