Cleared Traditional

K180875 - POLY REJUV

K180875 is the FDA 510(k) clearance for POLY REJUV by Medtek Skincare, LLC. It is a Class 2 General & Plastic Surgery device (product code OHS) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K180875 · Medtek Skincare, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
164d
Days
Class 2
Risk

K180875 is an FDA 510(k) clearance for the POLY REJUV. Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Medtek Skincare, LLC (Hudson, US). The FDA issued a Cleared decision on September 14, 2018 after a review of 164 days - an extended review 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: 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 Medtek Skincare, LLC devices

Submission Details

510(k) Number K180875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2018
Decision Date September 14, 2018
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
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

Aegis Regulatory, Inc.
Susan Anthoney-Dewet

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 119
Devices cleared under the same product code (OHS) and FDA review panel - the closest regulatory comparables to K180875.
MMSphere
K190443 · Galactic Beauty, LLC · Jun 2019
dpl Faceware
K183247 · Led Technologies, Inc. · Mar 2019
LG PRA.L DERMA LED MASK
K183671 · Lg Electronics.Inc · Jan 2019
Avologi ENEO
K181659 · Premier North America, Inc. · Jul 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