FDA 510(k)

IPLヘア除去装置（SYL001AZ、SYL002AZ）

K番号: K253035 · 2025-11-19

申請者Gu'An Yeolight Smart Electronics Co., Ltd.

決定日2025-11-19

製品コードOHT

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

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IPLヘア除去装置（SYL001AZ、SYL002AZ）

医療機器の概要

よくある質問

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関連機器（コード：OHT）

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