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FDA 510(k)

E-PEN (E-PEN)

K-Number: K243143 · 2025-04-07

ApplicantBomtech Electronics Co., Ltd.
Decision Date2025-04-07
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

E-PEN (E-PEN) is the device name listed in this FDA 510(k) record. The listed applicant is Bomtech Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-04-07 under 510(k) number K243143. 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 E-PEN (E-PEN)?

E-PEN (E-PEN) is a medical device that received FDA 510(k) clearance on 2025-04-07. The listed applicant is Bomtech Electronics Co., Ltd.. The 510(k) number is K243143.

When did E-PEN (E-PEN) receive FDA 510(k) clearance?

E-PEN (E-PEN) received FDA 510(k) clearance on 2025-04-07, under 510(k) number K243143.

Who is the listed applicant for E-PEN (E-PEN)?

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

What is the FDA product code for E-PEN (E-PEN)?

The FDA product code for E-PEN (E-PEN) is QAI.

Other records listing Bomtech Electronics Co., Ltd. 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.

K243097RM STAR EX with RMS Needle

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.K253153SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLCK243800PRO Pen Microneedling System (6883)Dermalogica, LLCK2434721NEED ProCampomats S.R.L.

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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