Cleared Traditional

Sebacia Microparticles (K181518) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K181518 · Sebacia, Inc. · General & Plastic Surgery device
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Sep 2018
Decision
90d
Days
Class 2
Risk

K181518 is an FDA 510(k) clearance for the Sebacia Microparticles. Classified as Laser Absorbing Particles (product code QCY), Class II - Special Controls.

Submitted by Sebacia, Inc. (Duluth, US). The FDA issued a Cleared decision on September 6, 2018 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sebacia, Inc. devices

Submission Details

510(k) Number K181518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2018
Decision Date September 06, 2018
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QCY Laser Absorbing Particles
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Particles Are Applied To The Target Tissue(s) For The Purpose Of Absorbing Laser/light Energy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
John J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT03303170 Completed Interventional Industry-sponsored

Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris

A Prospective, Multicenter, Randomized, Controlled, Evaluator-Blinded Study of the Safety and Effectiveness of Sebacia Microparticles as an Accessory to 1064 nm Nd:Yag Laser in the Treatment of Facial Inflammatory Acne Vulgaris

168
Patients (actual)
11
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Acne Vulgaris
Study design Parallel
Eligibility All sexes · 12 Years+
Sponsor Sebacia, Inc. (industry)
Started 2017-09-25 → Primary completion 2018-04-10
Primary outcome
Change in number of inflammatory acne lesions
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov