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FDA 510(k)

Intense Pulsed Light Treatment System

K-Number: K192521 · 2019-12-06

ApplicantShangdong Huamei Technology Co., Ltd.
Decision Date2019-12-06
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulsed Light Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Shangdong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K192521. 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 Treatment System?

Intense Pulsed Light Treatment System is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Shangdong Huamei Technology Co., Ltd.. The 510(k) number is K192521.

When did Intense Pulsed Light Treatment System receive FDA 510(k) clearance?

Intense Pulsed Light Treatment System received FDA 510(k) clearance on 2019-12-06, under 510(k) number K192521.

Who is the listed applicant for Intense Pulsed Light Treatment System?

The FDA 510(k) record lists Shangdong Huamei Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intense Pulsed Light Treatment System?

The FDA product code for Intense Pulsed Light Treatment System 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.

NCT04920396Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland DysfunctionWITHDRAWNNCT07474883Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne VulgarisRECRUITINGNCT07599709LONG 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 RosaceaCOMPLETEDNCT07789002Multimodal Laser Treatment of Photodamaged SkinNOT_YET_RECRUITING

Other records listing Shangdong Huamei Technology 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.

K230816Intense Pulsed Light Treatment SystemK202758Nd: YAG Laser Therapy Systems HM-YL900K200751Photodynamic Therapy (PDT) EquipmentK192528CO2 Laser Therapy System

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.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.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.

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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