Cleared Special

K091446 - MODIFICATION TO LUX1540 HANDPIECE AND L...

K091446 is an FDA 510(k) clearance for MODIFICATION TO LUX1540 HANDPIECE AND L..., manufactured by Palomar Medical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code ONG cleared through the Special 510(k) pathway after a 165-day FDA review.

K091446 · Palomar Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
165d
Days
Class 2
Risk

K091446 is an FDA 510(k) clearance for the MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE. Classified as Powered Laser Surgical Instrument With Microbeamfractional Output (product code ONG), Class II - Special Controls.

Submitted by Palomar Medical Products, Inc. (Burlington, US). The FDA issued a Cleared decision on October 27, 2009 after a review of 165 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. 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.

View all Palomar Medical Products, Inc. devices

FDA 510(k) Submission Details - K091446

510(k) Number K091446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2009
Decision Date October 27, 2009
Days to Decision 165 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
50d slower than avg
Panel avg: 115d · This submission: 165d
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 19
Devices cleared under the same product code (ONG) and FDA review panel - the closest regulatory comparables to K091446.
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