Cleared Traditional

Avologi ENEO (K181659) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181659 · Premier North America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
31d
Days
Class 2
Risk

K181659 is an FDA 510(k) clearance for the Avologi ENEO. Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Premier North America, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on July 26, 2018 after a review of 31 days - a notably fast clearance cycle.

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: 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 Premier North America, Inc. devices

Submission Details

510(k) Number K181659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2018
Decision Date July 26, 2018
Days to Decision 31 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
84d faster than avg
Panel avg: 115d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OHS Light Based Over The Counter Wrinkle Reduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Shanghai CV Technology Co., Ltd.
Doris Dong

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.

Regulatory Peers - OHS Light Based Over The Counter Wrinkle Reduction

All 117
Devices cleared under the same product code (OHS) and FDA review panel - the closest regulatory comparables to K181659.
dpl Faceware
K183247 · Led Technologies, Inc. · Mar 2019
LG PRA.L DERMA LED MASK
K183671 · Lg Electronics.Inc · Jan 2019
POLY REJUV
K180875 · Medtek Skincare, LLC · Sep 2018
Neutrogena Light Therapy Aging Mask+
K180856 · Johnson & Johnson Consumer, Inc. · Jun 2018
ELEVARE, PERFECTIO 4
K172909 · Omm Imports D/B/A Zero Gravity · Jun 2018
reVive Light Therapy LED Ultrasonic Wrinkle System
K180445 · Led Technologies, Inc. · May 2018