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FDA 510(k)

SHINY RPL System

K-Number: K181868 · 2018-10-05

ApplicantIds, Ltd.
Decision Date2018-10-05
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHINY RPL System is the device name listed in this FDA 510(k) record. The listed applicant is Ids, Ltd.. It received FDA 510(k) clearance on 2018-10-05 under 510(k) number K181868. 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 SHINY RPL System?

SHINY RPL System is a medical device that received FDA 510(k) clearance on 2018-10-05. The listed applicant is Ids, Ltd.. The 510(k) number is K181868.

When did SHINY RPL System receive FDA 510(k) clearance?

SHINY RPL System received FDA 510(k) clearance on 2018-10-05, under 510(k) number K181868.

Who is the listed applicant for SHINY RPL System?

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

What is the FDA product code for SHINY RPL System?

The FDA product code for SHINY RPL System is ONF.

Other records listing Ids, 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.

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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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