Cleared Traditional

K123435 - IPL THERAPY SYSTEM

K123435 is an FDA 510(k) clearance for IPL THERAPY SYSTEM, manufactured by Beijing Sincoheren S&T Development Co, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code ONF cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K123435 · Beijing Sincoheren S&T Development Co, Ltd. · General & Plastic Surgery device
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Feb 2013
Decision
96d
Days
Class 2
Risk

K123435 is an FDA 510(k) clearance for the IPL THERAPY SYSTEM. Classified as Powered Light Based Non-laser Surgical Instrument With Thermal Effect (product code ONF), Class II - Special Controls.

Submitted by Beijing Sincoheren S&T Development Co, Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on February 11, 2013 after a review of 96 days - within the typical 510(k) review window.

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 Beijing Sincoheren S&T Development Co, Ltd. devices

FDA 510(k) Submission Details - K123435

510(k) Number K123435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2012
Decision Date February 11, 2013
Days to Decision 96 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 115d · This submission: 96d
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 34
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