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FDA 510(k)

IPL Hair Removal Device (SYL001AZ, SYL002AZ)

K-Number: K253035 · 2025-11-19

ApplicantGu'An Yeolight Smart Electronics Co., Ltd.
Decision Date2025-11-19
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device (SYL001AZ, SYL002AZ) is the device name listed in this FDA 510(k) record. The listed applicant is Gu'An Yeolight Smart Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-11-19 under 510(k) number K253035. 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 (SYL001AZ, SYL002AZ)?

IPL Hair Removal Device (SYL001AZ, SYL002AZ) is a medical device that received FDA 510(k) clearance on 2025-11-19. The listed applicant is Gu'An Yeolight Smart Electronics Co., Ltd.. The 510(k) number is K253035.

When did IPL Hair Removal Device (SYL001AZ, SYL002AZ) receive FDA 510(k) clearance?

IPL Hair Removal Device (SYL001AZ, SYL002AZ) received FDA 510(k) clearance on 2025-11-19, under 510(k) number K253035.

Who is the listed applicant for IPL Hair Removal Device (SYL001AZ, SYL002AZ)?

The FDA 510(k) record lists Gu'An Yeolight Smart 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 Device (SYL001AZ, SYL002AZ)?

The FDA product code for IPL Hair Removal Device (SYL001AZ, SYL002AZ) is OHT.

Related Clinical Trials

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: 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

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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