Cleared Traditional

K162366 - Omega VL

K162366 is the FDA 510(k) clearance for Omega VL by Ov World Co., Ltd.. It is a Class 2 General & Plastic Surgery device (product code NEW) cleared through the Traditional 510(k) pathway after a 556-day FDA review.

K162366 · Ov World Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
556d
Days
Class 2
Risk

K162366 is an FDA 510(k) clearance for the Omega VL. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Ov World Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on March 2, 2018 after a review of 556 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Ov World Co., Ltd. devices

Submission Details

510(k) Number K162366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2016
Decision Date March 02, 2018
Days to Decision 556 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
441d slower than avg
Panel avg: 115d · This submission: 556d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
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

Onbix Corporation
HO DONG YANG

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 - NEW Suture, Surgical, Absorbable, Polydioxanone

All 27
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K162366.
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
K182873 · Ethicon, Inc. · Jan 2019
Miracu
K172602 · Feeltech Co., Ltd. · Nov 2018
DemeTECH DemeDIOX absorbable surgical suture
K181582 · Demetech Corporation · Aug 2018
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
K150670 · Ethicon, Inc. · Jul 2015
STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
K141776 · Ethicon, Inc. · Oct 2014
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
K120284 · Coloplast A/S · May 2012