FDA 510(k)

Automatic Micro Needle System (CODE-X)

Номер K: K252591 · 2026-05-13

Дата решения2026-05-13

Код продуктаQAI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Automatic Micro Needle System (CODE-X) is the device name listed in this FDA 510(k) record. The listed applicant is Woorhi Mechatronics Co., Ltd.. It received FDA 510(k) clearance on 2026-05-13 under 510(k) number K252591. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Automatic Micro Needle System (CODE-X)?

Automatic Micro Needle System (CODE-X) is a medical device that received FDA 510(k) clearance on 2026-05-13. The listed applicant is Woorhi Mechatronics Co., Ltd.. The 510(k) number is K252591.

When did Automatic Micro Needle System (CODE-X) receive FDA 510(k) clearance?

Automatic Micro Needle System (CODE-X) received FDA 510(k) clearance on 2026-05-13, under 510(k) number K252591.

Who is the listed applicant for Automatic Micro Needle System (CODE-X)?

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

What is the FDA product code for Automatic Micro Needle System (CODE-X)?

The FDA product code for Automatic Micro Needle System (CODE-X) is QAI.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: QAI)

K253002SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc.K252752ellacor System with Micro-Coring TechnologyCytrellis Biosystems, Inc.K253153SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC K243800PRO Pen Microneedling System (6883)Dermalogica, LLC K243143E-PEN (E-PEN)Bomtech Electronics Co., Ltd.K2434721NEED ProCampomats S.R.L.

Официальный источник

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