Cleared Traditional

K121598 - ME HAIR2GO

K121598 is an FDA 510(k) clearance for ME HAIR2GO, manufactured by Syneron Medical, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code ONF cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K121598 · Syneron Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Oct 2012
Decision
134d
Days
Class 2
Risk

K121598 is an FDA 510(k) clearance for the ME HAIR2GO. Classified as Powered Light Based Non-laser Surgical Instrument With Thermal Effect (product code ONF), Class II - Special Controls.

Submitted by Syneron Medical, Ltd. (Philedelphia, US). The FDA issued a Cleared decision on October 12, 2012 after a review of 134 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 Syneron Medical, Ltd. devices

FDA 510(k) Submission Details - K121598

510(k) Number K121598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2012
Decision Date October 12, 2012
Days to Decision 134 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
19d slower than avg
Panel avg: 115d · This submission: 134d
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 61
Devices cleared under the same product code (ONF) and FDA review panel - the closest regulatory comparables to K121598.
IPL THERAPY SYSTEM
K123435 · Beijing Sincoheren S&T Development Co, Ltd. · Feb 2013
INTENSE PULSED LIGHT (IPL) SYSTEMS
K122995 · Beijing Kes Biology Technology Co., Ltd. · Jan 2013
ME
K123845 · Syneron Beauty , Ltd. · Jan 2013
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
K121515 · Solta Medical, Inc. · Jun 2012
SHASER HRS2 HAIR REMOVAL SYSTEM
K120080 · Shaser, Inc. · May 2012
MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM
K111350 · Medicam, Inc. · Sep 2011