Cleared Special

K141583 - SHASER SKIN BEAUTY INTENSE PULSED LIGHT...

K141583 is an FDA 510(k) clearance for SHASER SKIN BEAUTY INTENSE PULSED LIGHT..., manufactured by Shaser, Inc.. The device is a Class 2 General & Plastic Surgery device with product code ONF cleared through the Special 510(k) pathway after a 39-day FDA review.

K141583 · Shaser, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
39d
Days
Class 2
Risk

K141583 is an FDA 510(k) clearance for the SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY. Classified as Powered Light Based Non-laser Surgical Instrument With Thermal Effect (product code ONF), Class II - Special Controls.

Submitted by Shaser, Inc. (Lexington, US). The FDA issued a Cleared decision on July 22, 2014 after a review of 39 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Shaser, Inc. devices

FDA 510(k) Submission Details - K141583

510(k) Number K141583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2014
Decision Date July 22, 2014
Days to Decision 39 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

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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