Cleared Traditional

K241355 - SER Pen Carain MicroSystem (MP1209SP) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241355 · Su-Ko Technologies, LLC · General & Plastic Surgery device
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Oct 2024
Decision
148d
Days
Class 2
Risk

K241355 is an FDA 510(k) clearance for the SER Pen Carain MicroSystem (MP1209SP). Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Su-Ko Technologies, LLC (Houston, US). The FDA issued a Cleared decision on October 9, 2024 after a review of 148 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4430 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Su-Ko Technologies, LLC devices

Submission Details

510(k) Number K241355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2024
Decision Date October 09, 2024
Days to Decision 148 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 114d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QAI Powered Microneedle Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4430
Definition A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Contract In-House Counsel and Consultants,
Marc Sanchez, Esq.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QAI Powered Microneedle Device

All 24
Devices cleared under the same product code (QAI) and FDA review panel - the closest regulatory comparables to K241355.
SkinStylus SteriLock MicroSystem (MP1209SL)
K253002 · Esthetic Medical, Inc. · Feb 2026
ellacor System with Micro-Coring Technology
K252752 · Cytrellis Biosystems, Inc. · Oct 2025
SER Pen Carain MicroSystem (MP1209SP)
K253153 · Su-Ko Technologies, LLC · Oct 2025
PRO Pen Microneedling System (6883)
K243800 · Dermalogica, LLC · Aug 2025
E-PEN (E-PEN)
K243143 · Bomtech Electronics Co., Ltd. · Apr 2025
1NEED Pro
K243472 · Campomats S.R.L. · Mar 2025