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FDA 510(k)

Intense Pulsed Light Therapy Device

K-Number: K261204 · 2026-06-12

ApplicantSanhe LEFIS Electronics Co., Ltd.
Decision Date2026-06-12
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulsed Light Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Sanhe LEFIS Electronics Co., Ltd.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K261204. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intense Pulsed Light Therapy Device?

Intense Pulsed Light Therapy Device is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Sanhe LEFIS Electronics Co., Ltd.. The 510(k) number is K261204.

When did Intense Pulsed Light Therapy Device receive FDA 510(k) clearance?

Intense Pulsed Light Therapy Device received FDA 510(k) clearance on 2026-06-12, under 510(k) number K261204.

Who is the listed applicant for Intense Pulsed Light Therapy Device?

The FDA 510(k) record lists Sanhe LEFIS Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intense Pulsed Light Therapy Device?

The FDA product code for Intense Pulsed Light Therapy Device is ONF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07474883Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne VulgarisRECRUITINGNCT04920396Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland DysfunctionWITHDRAWNNCT07599709LONG PULSED ND:YAG LASER (1064 NM) VERSUS INTENSE PULSED LIGHT IN TREATMENT OF TRAUMATIC AND POST-SURGICAL ERYTHEMATOUS SCARSCOMPLETEDNCT07729540Efficacy of IPL, an Anti-redness Dermocosmetic, and Their Combination in the Treatment of RosaceaCOMPLETED

Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 29060903Development of evaluation methods for the approval and review of Intense pulsed light (IPL).Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2017)

Other records listing Sanhe LEFIS Electronics Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250998CO2 Laser Therapy System (Model: LFS-D9U)K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)

Related Devices (Code: ONF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.K240314MULA (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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