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FDA 510(k)

IPL Hair Removal, Model: OBT-02

K-Number: K213041 · 2021-11-18

ApplicantGlan Electronics Co., Ltd.
Decision Date2021-11-18
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal, Model: OBT-02 is the device name listed in this FDA 510(k) record. The listed applicant is Glan Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K213041. 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, Model: OBT-02?

IPL Hair Removal, Model: OBT-02 is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Glan Electronics Co., Ltd.. The 510(k) number is K213041.

When did IPL Hair Removal, Model: OBT-02 receive FDA 510(k) clearance?

IPL Hair Removal, Model: OBT-02 received FDA 510(k) clearance on 2021-11-18, under 510(k) number K213041.

Who is the listed applicant for IPL Hair Removal, Model: OBT-02?

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

What is the FDA product code for IPL Hair Removal, Model: OBT-02?

The FDA product code for IPL Hair Removal, Model: OBT-02 is OHT.

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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.

K261975Braun Aura 7 (6041)CyDen LimitedK261977Braun Aura 9 (6042)Cyden LimitedK262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)ONE BEAUTY Technology Co., Ltd.K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)Shenzhen Xiazhifeng Electronic 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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