Cleared Traditional

K172909 - ELEVARE

K172909 is the FDA 510(k) clearance for ELEVARE by Omm Imports D/B/A Zero Gravity. It is a Class 2 General & Plastic Surgery device (product code OHS) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K172909 · Omm Imports D/B/A Zero Gravity · General & Plastic Surgery device
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Jun 2018
Decision
255d
Days
Class 2
Risk

K172909 is an FDA 510(k) clearance for the ELEVARE, PERFECTIO 4. Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Omm Imports D/B/A Zero Gravity (Doral, US). The FDA issued a Cleared decision on June 7, 2018 after a review of 255 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 Omm Imports D/B/A Zero Gravity devices

Submission Details

510(k) Number K172909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2017
Decision Date June 07, 2018
Days to Decision 255 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
140d slower than avg
Panel avg: 115d · This submission: 255d
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, 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 K172909.
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