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FDA 510(k)

IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4

K-Number: K220222 · 2022-04-26

ApplicantShenzhen Yuwei Electronic Technology Co., Ltd.
Decision Date2022-04-26
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 is a medical device manufactured by Shenzhen Yuwei Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-26 under approval number K220222. 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): S1-A, S2-A, S1, S2, S3, S4?

IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 is a medical device that received FDA 510(k) clearance on 2022-04-26. It is manufactured by Shenzhen Yuwei Electronic Technology Co., Ltd.. The 510(k) number is K220222.

When was IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 approved by the FDA?

IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 received FDA 510(k) clearance on 2022-04-26, under approval number K220222.

What company makes IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4?

IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 is manufactured by Shenzhen Yuwei Electronic Technology Co., Ltd..

What is the FDA product code for IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4?

The FDA product code for IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 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

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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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