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FDA 510(k)

SkinStylus SteriLock® MicroSystem, Model Number MP1209SL

K-Number: K231073 · 2023-07-28

ApplicantEsthetic Medical, Inc.
Decision Date2023-07-28
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SkinStylus SteriLock® MicroSystem, Model Number MP1209SL is a medical device manufactured by Esthetic Medical, Inc.. It received FDA 510(k) clearance on 2023-07-28 under approval number K231073. 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 SkinStylus SteriLock® MicroSystem, Model Number MP1209SL?

SkinStylus SteriLock® MicroSystem, Model Number MP1209SL is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Esthetic Medical, Inc.. The 510(k) number is K231073.

When was SkinStylus SteriLock® MicroSystem, Model Number MP1209SL approved by the FDA?

SkinStylus SteriLock® MicroSystem, Model Number MP1209SL received FDA 510(k) clearance on 2023-07-28, under approval number K231073.

What company makes SkinStylus SteriLock® MicroSystem, Model Number MP1209SL?

SkinStylus SteriLock® MicroSystem, Model Number MP1209SL is manufactured by Esthetic Medical, Inc..

What is the FDA product code for SkinStylus SteriLock® MicroSystem, Model Number MP1209SL?

The FDA product code for SkinStylus SteriLock® MicroSystem, Model Number MP1209SL is QAI.

Related Clinical Trials

NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT07561372 Adaptive Recruitment Curve Analysis Using Bayesian Modeling NOT_YET_RECRUITING NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING NCT06534073 Baropodometric Patterns Associated With Metatarsalgia ACTIVE_NOT_RECRUITING NCT07367620 Immediate Mechanical Complications After Central Venous Catheterization COMPLETED NCT07539727 Clinical Value of Intestinal Ultrasound in Predicting Clinical Relapse in Crohn's Disease Patients in Deep Remission: a Multicenter Prospective Observational Study RECRUITING

Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026)

Other Devices by Esthetic Medical, Inc.

K253002SkinStylus SteriLock MicroSystem (MP1209SL)

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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