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FDA 510(k)

SER Pen Carain MicroSystem (MP1209SP)

K-Number: K253153 · 2025-10-29

ApplicantSu-Ko Technologies, LLC
Decision Date2025-10-29
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SER Pen Carain MicroSystem (MP1209SP) is the device name listed in this FDA 510(k) record. The listed applicant is Su-Ko Technologies, LLC. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K253153. 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 SER Pen Carain MicroSystem (MP1209SP)?

SER Pen Carain MicroSystem (MP1209SP) is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Su-Ko Technologies, LLC. The 510(k) number is K253153.

When did SER Pen Carain MicroSystem (MP1209SP) receive FDA 510(k) clearance?

SER Pen Carain MicroSystem (MP1209SP) received FDA 510(k) clearance on 2025-10-29, under 510(k) number K253153.

Who is the listed applicant for SER Pen Carain MicroSystem (MP1209SP)?

The FDA 510(k) record lists Su-Ko Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SER Pen Carain MicroSystem (MP1209SP)?

The FDA product code for SER Pen Carain MicroSystem (MP1209SP) is QAI.

Other records listing Su-Ko Technologies, LLC 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.

K241355SER Pen Carain MicroSystem (MP1209SP)

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.

K252591Automatic Micro Needle System (CODE-X)Woorhi Mechatronics Co., Ltd.K253002SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc.K252752ellacor System with Micro-Coring TechnologyCytrellis Biosystems, Inc.K243800PRO 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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