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FDA 510(k)

Intense Pulsed Light System

K-Number: K231394 · 2023-08-09

ApplicantSmedtrum Medical Technology Co., Ltd.
Decision Date2023-08-09
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulsed Light System is the device name listed in this FDA 510(k) record. The listed applicant is Smedtrum Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-09 under 510(k) number K231394. 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 System?

Intense Pulsed Light System is a medical device that received FDA 510(k) clearance on 2023-08-09. The listed applicant is Smedtrum Medical Technology Co., Ltd.. The 510(k) number is K231394.

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

Intense Pulsed Light System received FDA 510(k) clearance on 2023-08-09, under 510(k) number K231394.

Who is the listed applicant for Intense Pulsed Light System?

The FDA 510(k) record lists Smedtrum Medical 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 System?

The FDA product code for Intense Pulsed Light 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 Smedtrum Medical 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.

K240482Intense Pulsed Light System (ST-690)K240118Picosecond Nd:YAG Laser SystemK230580Diode Laser SystemK221597CO2 Laser 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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