DeviceClearance

SER Pen Carain MicroSystem (MP1209SP)— 510(k) K241355

Substantially Equivalent

Su-Ko Technologies, LLC

FDA 510(k) clearance K241355 for SER Pen Carain MicroSystem (MP1209SP), Substantially Equivalent on 2024-10-09. Applicant: Su-Ko Technologies, LLC. Device class: 2.

Clearance details

Applicant
Su-Ko Technologies, LLC
Product code
Code QAI
Device class
Class 2
Regulation
21 CFR 878.4430
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Houston, TX, US
Download summary PDFView on FDA.gov ↗

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