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SER Pen Carain MicroSystem (MP1209SP)

by Su-Ko Technologies, LLC 2 variants

510(k) K241355

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241355 Date9 Oct 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QAI
Device Class
Class II
Regulation
21 CFR Part 878.4430
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SER Pen Carain MicroSystem (MP1209SP) is a powered microneedle device. It is a handheld device that creates channels and microinjuries into the skin through a DC motor drive system that rapidly reciprocates.

It is supplied as a non-sterile, reusable device intended for use in general and plastic surgery settings. The device has received FDA 510(k) clearance under K241355 and is classified as a Class II device under regulation number 878.4430.

Other devices from Su-Ko Technologies, LLC

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SER Pen Carain MicroSystem (MP1209SP) used for?

    The SER Pen Carain MicroSystem (MP1209SP) is a powered microneedle device designed to create channels and microinjuries in the skin through rapid reciprocation driven by a DC motor. It is intended for use in general and plastic surgery settings to facilitate procedures requiring precise dermal penetration.

  • Is the SER Pen Carain MicroSystem (MP1209SP) sterile or non-sterile, and is it reusable?

    The device is supplied as non-sterile and is designed for reuse. It must be cleaned and sterilized by the user according to established protocols before each use, as it is not provided in a sterile condition.

  • How does the SER Pen Carain MicroSystem (MP1209SP) operate?

    The device operates using a DC motor drive system that rapidly reciprocates the microneedle tip to create controlled microchannels and microinjuries in the skin. This powered mechanism allows for consistent and precise penetration depth during procedures.

  • What regulatory clearance does the SER Pen Carain MicroSystem (MP1209SP) have?

    The SER Pen Carain MicroSystem (MP1209SP) has received FDA 510(k) clearance under submission number K241355 and is classified as a Class II medical device under regulation 878.4430, indicating it is substantially equivalent to a legally marketed predicate device.

  • Who manufactures the SER Pen Carain MicroSystem (MP1209SP) and where is it located?

    The SER Pen Carain MicroSystem (MP1209SP) is manufactured by Su-Ko Technologies, LLC, located at 700 Smith St., #61070, Houston, TX 77002, United States. The company is listed as the applicant in the FDA 510(k) submission.