Cleared Traditional

K160880 - Photonica Professional

K160880 is an FDA 510(k) clearance for Photonica Professional, manufactured by Ward Photonics, LLC. The device is a Class 2 General & Plastic Surgery device with product code OLI cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K160880 · Ward Photonics, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
177d
Days
Class 2
Risk

K160880 is an FDA 510(k) clearance for the Photonica Professional. Classified as Fat Reducing Low Level Laser within the OLI classification (a category for non-invasive low-level laser body contouring systems), Class II - Special Controls.

Submitted by Ward Photonics, LLC (Cocoa Beach, US). The FDA issued a Cleared decision on September 23, 2016 after a review of 177 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5400 - 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 Ward Photonics, LLC devices

FDA 510(k) Submission Details - K160880

510(k) Number K160880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2016
Decision Date September 23, 2016
Days to Decision 177 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
62d slower than avg
Panel avg: 115d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

OLI Device Classification - Class 2, Special Controls

Product Code OLI Fat Reducing Low Level Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5400
Definition Non-invasive Reduction In Fat Layer For Body Contouring
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.

Regulatory Consultant

Alliance Lifescience Partnerships, LLC
Jeff Brown

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.

Clinical Evidence

ClinicalTrials.gov
NCT02867150 Completed Interventional Industry-sponsored

A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring

58
Patients (actual)
Treatment
Purpose
Open label
Masking
Condition studied Obesity
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Terry J Ward, M.H.A.
Sponsor Ward Photonics LLC (industry)
Started 2015-10-01 → Primary completion 2015-10-01
Primary outcome
Fat Reduction in Treatment Zone as Measured in Inches Lost
View full study on ClinicalTrials.gov

Regulatory Peers - OLI Fat Reducing Low Level Laser

All 32
Devices cleared under the same product code (OLI) and FDA review panel - the closest regulatory comparables to K160880.
Vevazz LED
K172111 · Vevazz, LLC · Nov 2017
CURVE Laser System
K170709 · Yolo Medical, Inc. · Jun 2017
Zerona Z6 OTC
K162578 · Erchonia Corporation · Dec 2016
Erchonia Zerona 6 headed scanner EZ6
K150446 · Erchonia Corporation · May 2015
Lipofina Laser System
K143741 · Yolo Medical, Inc. · Apr 2015
Erchonia Zerona Z6 OTC
K143007 · Erchonia Corporation · Jan 2015