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FDA 510(k)

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)

K-Number: K242595 · 2024-11-07

ApplicantShenzhen Greatro Electronic Technology Co., Ltd.
Decision Date2024-11-07
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Greatro Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-07 under 510(k) number K242595. 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 Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)?

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Shenzhen Greatro Electronic Technology Co., Ltd.. The 510(k) number is K242595.

When did Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) receive FDA 510(k) clearance?

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) received FDA 510(k) clearance on 2024-11-07, under 510(k) number K242595.

Who is the listed applicant for Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)?

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

What is the FDA product code for Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)?

The FDA product code for Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) 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.

NCT07169461Effectiveness of Low Level Light Therapy and Intense Pulse Light on Mite Count as Adjuntive Therapies in Demodex Blepharitis Using Artificial Intelligent Program (Ai-Demodex)COMPLETEDNCT07474883Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne VulgarisRECRUITINGNCT06432881Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)COMPLETEDNCT07729540Efficacy of IPL, an Anti-redness Dermocosmetic, and Their Combination in the Treatment of RosaceaCOMPLETEDNCT07789002Multimodal Laser Treatment of Photodamaged SkinNOT_YET_RECRUITING

Other records listing Shenzhen Greatro Electronic 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.

K232932Intense Pulse Light Therapeutic Apparatus

Related Devices (Code: OHT)

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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