Cleared Special

K110984 - SLIM E30 II CO2 LASER

K110984 is an FDA 510(k) clearance for SLIM E30 II CO2 LASER, manufactured by Lasering S.R.L.. The device is a Class 2 General & Plastic Surgery device with product code ONG cleared through the Special 510(k) pathway after a 106-day FDA review.

K110984 · Lasering S.R.L. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
106d
Days
Class 2
Risk

K110984 is an FDA 510(k) clearance for the SLIM E30 II CO2 LASER. Classified as Powered Laser Surgical Instrument With Microbeamfractional Output (product code ONG), Class II - Special Controls.

Submitted by Lasering S.R.L. (San Ramon, US). The FDA issued a Cleared decision on July 22, 2011 after a review of 106 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110984

510(k) Number K110984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2011
Decision Date July 22, 2011
Days to Decision 106 days
Submission Type Special
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
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

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 34
Devices cleared under the same product code (ONG) and FDA review panel - the closest regulatory comparables to K110984.
CLEAR + BRILLIANT LASER SYSTEM
K120433 · Solta Medical, Inc. · Apr 2012
MX-7000 MICROXEL
K111831 · Bio-Med USA, Inc. · Dec 2011
EMERGE FRACTIONAL LASER
K111840 · Palomar Medical Products, Inc. · Nov 2011
CLEAR+BRILLIANT LASER SYSTEM
K110349 · Solta Medical, Inc. · May 2011
PRIMUS AESTHETIC PLATFORM
K103664 · Palomar Medical Technologies, Inc. · Mar 2011
LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
K100610 · Lutronic Corporation · Jan 2011
K110984 · SLIM E30 II CO2 LASER
Download PDF FDA Summary Lasering S.R.L.