Cleared Abbreviated

K061117 - NANOLITE SKIN CARE SYSTEM

K061117 is an FDA 510(k) clearance for NANOLITE SKIN CARE SYSTEM, manufactured by Nanolite Technology, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Abbreviated 510(k) pathway after a 60-day FDA review.

K061117 · Nanolite Technology, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jun 2006
Decision
60d
Days
Class 2
Risk

K061117 is an FDA 510(k) clearance for the NANOLITE SKIN CARE 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 Nanolite Technology, Inc. (Torrance, US). The FDA issued a Cleared decision on June 20, 2006 after a review of 60 days - a notably fast clearance 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nanolite Technology, Inc. devices

FDA 510(k) Submission Details - K061117

510(k) Number K061117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2006
Decision Date June 20, 2006
Days to Decision 60 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 1984
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K061117.
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