Cleared Traditional

K100487 - EQUINOX CO2 LASER SYSTEM

K100487 is an FDA 510(k) clearance for EQUINOX CO2 LASER SYSTEM, manufactured by Eclipsemed Global, Inc.. The device is a Class 2 General & Plastic Surgery device with product code ONG cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K100487 · Eclipsemed Global, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
283d
Days
Class 2
Risk

K100487 is an FDA 510(k) clearance for the EQUINOX CO2 LASER SYSTEM. Classified as Powered Laser Surgical Instrument With Microbeamfractional Output (product code ONG), Class II - Special Controls.

Submitted by Eclipsemed Global, Inc. (Dallas, US). The FDA issued a Cleared decision on November 29, 2010 after a review of 283 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.

View all Eclipsemed Global, Inc. devices

FDA 510(k) Submission Details - K100487

510(k) Number K100487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2010
Decision Date November 29, 2010
Days to Decision 283 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
168d slower than avg
Panel avg: 115d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ONG Device Classification - Class 2, Special Controls

Product Code ONG Powered Laser Surgical Instrument With Microbeamfractional Output
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. The Laser Output Is In Form Of Tiny Beams In Micro Range. Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic To Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue. 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, Remove Or Coagulate 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 - ONG Powered Laser Surgical Instrument With Microbeamfractional Output

All 21
Devices cleared under the same product code (ONG) and FDA review panel - the closest regulatory comparables to K100487.
EMERGE FRACTIONAL LASER
K111840 · Palomar Medical Products, Inc. · Nov 2011
PRIMUS AESTHETIC PLATFORM
K103664 · Palomar Medical Technologies, Inc. · Mar 2011
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K100610 · Lutronic Corporation · Jan 2011
FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
K101490 · Thermage, Inc. · Sep 2010
LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
K101506 · Palomar Medical Technologies, Inc. · Sep 2010
MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE
K091446 · Palomar Medical Products, Inc. · Oct 2009