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FDA 510(k)

Sebacia Microparticles

K-Number: K181518 · 2018-09-06

ApplicantSebacia, Inc.
Decision Date2018-09-06
Product CodeQCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sebacia Microparticles is the device name listed in this FDA 510(k) record. The listed applicant is Sebacia, Inc.. It received FDA 510(k) clearance on 2018-09-06 under 510(k) number K181518. The device is classified under product code QCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sebacia Microparticles?

Sebacia Microparticles is a medical device that received FDA 510(k) clearance on 2018-09-06. The listed applicant is Sebacia, Inc.. The 510(k) number is K181518.

When did Sebacia Microparticles receive FDA 510(k) clearance?

Sebacia Microparticles received FDA 510(k) clearance on 2018-09-06, under 510(k) number K181518.

Who is the listed applicant for Sebacia Microparticles?

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

What is the FDA product code for Sebacia Microparticles?

The FDA product code for Sebacia Microparticles is QCY.

Related Devices (Code: QCY)

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.

K192620SNA-001 Silver Photoparticle Topical GelSienna Biopharmaceuticals, Inc.

Official Source

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