Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SkinStylus SteriLock MicroSystem

K-Number: K200044 · 2020-04-10

ApplicantEsthetic Education, LLC
Decision Date2020-04-10
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SkinStylus SteriLock MicroSystem is the device name listed in this FDA 510(k) record. The listed applicant is Esthetic Education, LLC. It received FDA 510(k) clearance on 2020-04-10 under 510(k) number K200044. 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?

SkinStylus SteriLock MicroSystem is a medical device that received FDA 510(k) clearance on 2020-04-10. The listed applicant is Esthetic Education, LLC. The 510(k) number is K200044.

When did SkinStylus SteriLock MicroSystem receive FDA 510(k) clearance?

SkinStylus SteriLock MicroSystem received FDA 510(k) clearance on 2020-04-10, under 510(k) number K200044.

Who is the listed applicant for SkinStylus SteriLock MicroSystem?

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

What is the FDA product code for SkinStylus SteriLock MicroSystem?

The FDA product code for SkinStylus SteriLock MicroSystem is QAI.

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.

↑