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FDA 510(k)

IPL + Diode Laser Machine

K-Number: K193328 · 2020-03-25

ApplicantBeijing Globalipl Development Co., Ltd.
Decision Date2020-03-25
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL + Diode Laser Machine is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Globalipl Development Co., Ltd.. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K193328. 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 IPL + Diode Laser Machine?

IPL + Diode Laser Machine is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Beijing Globalipl Development Co., Ltd.. The 510(k) number is K193328.

When did IPL + Diode Laser Machine receive FDA 510(k) clearance?

IPL + Diode Laser Machine received FDA 510(k) clearance on 2020-03-25, under 510(k) number K193328.

Who is the listed applicant for IPL + Diode Laser Machine?

The FDA 510(k) record lists Beijing Globalipl Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL + Diode Laser Machine?

The FDA product code for IPL + Diode Laser Machine is ONF.

Other records listing Beijing Globalipl Development 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.

K222916US 450 Diode Laser EquipmentK220385Intense Pulsed Light EquipmentK212611CO2 Laser Equipment

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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