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FDA 510(k)

Automatic Micro Needle System (CODE-X)

K-Number: K252591 · 2026-05-13

ApplicantWoorhi Mechatronics Co., Ltd.
Decision Date2026-05-13
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: QAI)

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.

K253002SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc.K252752ellacor System with Micro-Coring TechnologyCytrellis Biosystems, Inc.K253153SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLCK243800PRO Pen Microneedling System (6883)Dermalogica, LLCK243143E-PEN (E-PEN)Bomtech Electronics Co., Ltd.K2434721NEED ProCampomats S.R.L.

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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