Cleared Traditional

K103560 - SHASER IPL HAIR REMOVAL SYSTEM

K103560 is an FDA 510(k) clearance for SHASER IPL HAIR REMOVAL SYSTEM, manufactured by Shaser, Inc.. The device is a Class 2 General & Plastic Surgery device with product code ONF cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K103560 · Shaser, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
166d
Days
Class 2
Risk

K103560 is an FDA 510(k) clearance for the SHASER IPL HAIR REMOVAL SYSTEM. Classified as Powered Light Based Non-laser Surgical Instrument With Thermal Effect (product code ONF), Class II - Special Controls.

Submitted by Shaser, Inc. (Melrose, US). The FDA issued a Cleared decision on May 18, 2011 after a review of 166 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 - K103560

510(k) Number K103560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2010
Decision Date May 18, 2011
Days to Decision 166 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
51d slower than avg
Panel avg: 115d · This submission: 166d
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 K103560.
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
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SHASER HRS2 HAIR REMOVAL SYSTEM
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K111350 · Medicam, Inc. · Sep 2011
IPL THERAPY SYSTEM
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IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650
K093627 · Shanghai Apolo Medical Technologies Co., Ltd. · Jan 2011
AHWON'S IPL SYSTEM
K102857 · Ahwon Medi Instrument Co., Ltd. · Jan 2011