Cleared Special

K082407 - MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM

K082407 is an FDA 510(k) clearance for MODIFICATION TO ULTRALIGHT II ND: YAG L..., manufactured by Sandstone Medical Technologies, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Special 510(k) pathway after a 166-day FDA review.

K082407 · Sandstone Medical Technologies, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
166d
Days
Class 2
Risk

K082407 is an FDA 510(k) clearance for the MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Sandstone Medical Technologies, LLC (Birmingham, US). The FDA issued a Cleared decision on February 3, 2009 after a review of 166 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.

FDA 510(k) Submission Details - K082407

510(k) Number K082407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2008
Decision Date February 03, 2009
Days to Decision 166 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
51d slower than avg
Panel avg: 115d · This submission: 166d
Pathway characteristics
Modification to existing cleared device.

GEX Device Classification - Class 2, Special Controls

Product Code GEX Powered Laser Surgical Instrument
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. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. 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 - GEX Powered Laser Surgical Instrument

All 2787
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K082407.
WATERLASE MD
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K082407 · MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM
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