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FDA 510(k)

Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)

K-Number: K241120 · 2024-06-24

ApplicantQiaocheng LI (Dongguan) Medical Instruments Co., Ltd.
Decision Date2024-06-24
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) is the device name listed in this FDA 510(k) record. The listed applicant is Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-06-24 under 510(k) number K241120. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)?

Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) is a medical device that received FDA 510(k) clearance on 2024-06-24. The listed applicant is Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.. The 510(k) number is K241120.

When did Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) receive FDA 510(k) clearance?

Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) received FDA 510(k) clearance on 2024-06-24, under 510(k) number K241120.

Who is the listed applicant for Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)?

The FDA 510(k) record lists Qiaocheng LI (Dongguan) Medical Instruments 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 apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)?

The FDA product code for Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) is OHT.

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 RosaceaCOMPLETEDNCT07789002Multimodal Laser Treatment of Photodamaged SkinNOT_YET_RECRUITING

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)

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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.

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Official Source

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