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FDA 510(k)

Diode Laser Hair Removal

K-Number: K230090 · 2023-04-19

ApplicantWuhan Lotuxs Technology Co., Ltd.
Decision Date2023-04-19
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Hair Removal is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Lotuxs Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-19 under 510(k) number K230090. 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 Diode Laser Hair Removal?

Diode Laser Hair Removal is a medical device that received FDA 510(k) clearance on 2023-04-19. The listed applicant is Wuhan Lotuxs Technology Co., Ltd.. The 510(k) number is K230090.

When did Diode Laser Hair Removal receive FDA 510(k) clearance?

Diode Laser Hair Removal received FDA 510(k) clearance on 2023-04-19, under 510(k) number K230090.

Who is the listed applicant for Diode Laser Hair Removal?

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

What is the FDA product code for Diode Laser Hair Removal?

The FDA product code for Diode Laser Hair Removal is OHT.

Other records listing Wuhan Lotuxs Technology 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.

K231910DermRays ReviveK232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)K191068Powersculp laser lipolysis system

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.

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.K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd.K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)Shenzhen Semlamp Intelligent Technology Co., Ltd.K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)Shenzhen Chuangtong Yigou Technology Co., Ltd.

Official Source

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