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FDA 510(k)

SkinPen Precision System

K-Number: K202243 · 2021-04-02

ApplicantCrown Aesthetics
Decision Date2021-04-02
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SkinPen Precision System is the device name listed in this FDA 510(k) record. The listed applicant is Crown Aesthetics. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K202243. 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 System?

SkinPen Precision System is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Crown Aesthetics. The 510(k) number is K202243.

When did SkinPen Precision System receive FDA 510(k) clearance?

SkinPen Precision System received FDA 510(k) clearance on 2021-04-02, under 510(k) number K202243.

Who is the listed applicant for SkinPen Precision System?

The FDA 510(k) record lists Crown Aesthetics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SkinPen Precision System?

The FDA product code for SkinPen Precision System is QAI.

Other records listing Crown Aesthetics 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.

K241400SkinPen Precision Elite SystemK220506SkinPen Precision System

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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