Cleared Traditional

K160195 - Forma System, Forma Light System

K160195 is an FDA 510(k) clearance for Forma System, manufactured by Formatk Systems , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code ONF cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K160195 · Formatk Systems , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
79d
Days
Class 2
Risk

K160195 is an FDA 510(k) clearance for the Forma System, Forma Light System. Classified as Powered Light Based Non-laser Surgical Instrument With Thermal Effect (product code ONF), Class II - Special Controls.

Submitted by Formatk Systems , Ltd. (Tirat Carmel, IL). The FDA issued a Cleared decision on April 15, 2016 after a review of 79 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 Formatk Systems , Ltd. devices

FDA 510(k) Submission Details - K160195

510(k) Number K160195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date April 15, 2016
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ONF Device Classification - Class 2, Special Controls

Product Code ONF Powered Light Based Non-laser Surgical Instrument With Thermal Effect
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Light Based Non-laser Device That Provides Thermal Effect Including Broad Spectrum Source Devices Such As Intense Pulse Light (ipl). Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic. Indication For Use Can Be General And/or Specific.the Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Or Remove Tissue By The Light.
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

A. Stein - Regulatory Affairs Consulting , Ltd.
AMIT GOREN

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 - ONF Powered Light Based Non-laser Surgical Instrument With Thermal Effect

All 61
Devices cleared under the same product code (ONF) and FDA review panel - the closest regulatory comparables to K160195.
Harmony XL Multi-Application Platform
K181298 · Alma Lasers, Inc. · Jun 2018
DUO
K161565 · Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd · Sep 2016
IPL Therapy Machine
K161286 · Beijing Adss Development Co., Ltd. · Aug 2016
Venus Versa System
K153717 · Venus Concept , Ltd. · Mar 2016
Venus Versa System
K152790 · Venus Concept , Ltd. · Jan 2016
Shaser Skin Beauty Intense Pulsed Light System Family for Acne
K150282 · Shaser, Inc. · May 2015