Cleared Traditional

K212399 - Aveli (FDA 510(k) Clearance)

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

K212399 · Nc8, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
81d
Days
Class 2
Risk

K212399 is an FDA 510(k) clearance for the Aveli. Classified as Powered Surgical Instrument For Improvement In The Appearance Of Cellulite (product code OUP), Class II - Special Controls.

Submitted by Nc8, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 22, 2021 after a review of 81 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4790 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nc8, Inc. devices

Submission Details

510(k) Number K212399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2021
Decision Date October 22, 2021
Days to Decision 81 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
33d faster than avg
Panel avg: 114d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4790
Definition Used For Controlled Release Of Subcutaneous Tissue For Improvement In The Appearance Of Cellulite.
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.

Clinical Evidence

ClinicalTrials.gov
NCT04743635 Completed Interventional Industry-sponsored

CONtrolled Focal Fibrous Band Release Method Study

74
Patients (actual)
9
Sites
Treatment
Purpose
Open label
Masking
Condition studied Cellulite
Study design Single group
Eligibility Female only · 21 Years+ · Healthy volunteers accepted
Principal investigator Dr. G. William Stevens, MD
Sponsor Revelle Aesthetics, Inc (industry)
Started 2021-01-07 → Primary completion 2021-06-14 → Completed 2022-03-04
Primary outcome
The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants
Secondary outcome
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months
View full study on ClinicalTrials.gov