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FDA 510(k)

SkinPen Precision Elite System

K-Number: K241400 · 2024-08-29

ApplicantCrown Aesthetics
Decision Date2024-08-29
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SkinPen Precision Elite System is a medical device manufactured by Crown Aesthetics. It received FDA 510(k) clearance on 2024-08-29 under approval number K241400. 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 SkinPen Precision Elite System?

SkinPen Precision Elite System is a medical device that received FDA 510(k) clearance on 2024-08-29. It is manufactured by Crown Aesthetics. The 510(k) number is K241400.

When was SkinPen Precision Elite System approved by the FDA?

SkinPen Precision Elite System received FDA 510(k) clearance on 2024-08-29, under approval number K241400.

What company makes SkinPen Precision Elite System?

SkinPen Precision Elite System is manufactured by Crown Aesthetics.

What is the FDA product code for SkinPen Precision Elite System?

The FDA product code for SkinPen Precision Elite System is QAI.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT05554133 Precision Optical Guidance for Oral Biopsy RECRUITING NCT07296276 Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM RECRUITING NCT06872684 Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD) RECRUITING

Other Devices by Crown Aesthetics

K202243SkinPen Precision System K220506SkinPen Precision System

Related Devices (Code: QAI)

K180778Exceed Microneedling DeviceMt. Derm GmbH DEN160029SkinPen Precision SystemBellus Medical, LLC K182407Exceed Microneedling deviceMt. Derm GmbH K200044SkinStylus SteriLock MicroSystemEsthetic Education, LLC K192138Rejuvapen NXTRefine USA, LLC K212558MicroPen EVOEclipse Medcorp, LLC

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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