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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 the device name listed in this FDA 510(k) record. The listed applicant is Esthetic Medical, Inc.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) 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. The listed applicant is Esthetic Medical, Inc.. The 510(k) number is K231073.

When did SkinStylus SteriLock® MicroSystem, Model Number MP1209SL receive FDA 510(k) clearance?

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

Who is the listed applicant for SkinStylus SteriLock® MicroSystem, Model Number MP1209SL?

The FDA 510(k) record lists Esthetic Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Esthetic Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253002SkinStylus SteriLock MicroSystem (MP1209SL)

Related Devices (Code: QAI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252591Automatic Micro Needle System (CODE-X)Woorhi Mechatronics Co., Ltd.K253002SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc.K252752ellacor System with Micro-Coring TechnologyCytrellis Biosystems, Inc.K253153SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLCK243800PRO Pen Microneedling System (6883)Dermalogica, LLCK243143E-PEN (E-PEN)Bomtech Electronics Co., Ltd.

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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