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FDA 510(k)

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi

K-Number: K222537 · 2022-10-14

ApplicantShenzhen Ishine Technology Company Limited
Decision Date2022-10-14
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi is a medical device manufactured by Shenzhen Ishine Technology Company Limited. It received FDA 510(k) clearance on 2022-10-14 under approval number K222537. 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 IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi?

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi is a medical device that received FDA 510(k) clearance on 2022-10-14. It is manufactured by Shenzhen Ishine Technology Company Limited. The 510(k) number is K222537.

When was IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi approved by the FDA?

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi received FDA 510(k) clearance on 2022-10-14, under approval number K222537.

What company makes IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi?

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi is manufactured by Shenzhen Ishine Technology Company Limited.

What is the FDA product code for IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi?

The FDA product code for IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi is OHT.

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Related PubMed Literature

PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 41079548 Clearing the airway? A pilot cadaveric study of the LifeVac™ device. Resuscitation plus (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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