Cleared Traditional

K090724 - OR-LIGHT

K090724 is an FDA 510(k) clearance for OR-LIGHT, manufactured by Yperion Technology. The device is a Class 2 General & Plastic Surgery device with product code ONF cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K090724 · Yperion Technology · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
202d
Days
Class 2
Risk

K090724 is an FDA 510(k) clearance for the OR-LIGHT. Classified as Powered Light Based Non-laser Surgical Instrument With Thermal Effect (product code ONF), Class II - Special Controls.

Submitted by Yperion Technology (Paris, FR). The FDA issued a Cleared decision on October 7, 2009 after a review of 202 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.

FDA 510(k) Submission Details - K090724

510(k) Number K090724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2009
Decision Date October 07, 2009
Days to Decision 202 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
87d slower than avg
Panel avg: 115d · This submission: 202d
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 Peers - ONF Powered Light Based Non-laser Surgical Instrument With Thermal Effect

All 73
Devices cleared under the same product code (ONF) and FDA review panel - the closest regulatory comparables to K090724.
SMOOTHCOOL
K092326 · Jeisys Medical, Inc. · Mar 2010
FUSION SYSTEM
K093465 · Eclipsemed Global, Inc. · Jan 2010
GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C
K091664 · Shenzhen Gsd Tech Co., Ltd. · Nov 2009
MINISILK FT
K082040 · El.En Electronic Engineering Spa · Aug 2009
STRATAPULSE TS AND STRATAPULSE
K090837 · Advanced Medical Photonics · Jun 2009
TRIOS SYSTEM
K090399 · Viora , Ltd. · Jun 2009
K090724 · OR-LIGHT
Download PDF FDA Summary Yperion Technology