Cleared Traditional

K160488 - Cutera enlighten III Laser System

K160488 is an FDA 510(k) clearance for Cutera enlighten III Laser System, manufactured by Cutera, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K160488 · Cutera, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
249d
Days
Class 2
Risk

K160488 is an FDA 510(k) clearance for the Cutera enlighten III 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 Cutera, Inc. (Brisbane, US). The FDA issued a Cleared decision on October 28, 2016 after a review of 249 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 Cutera, Inc. devices

FDA 510(k) Submission Details - K160488

510(k) Number K160488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2016
Decision Date October 28, 2016
Days to Decision 249 days
Submission Type Traditional
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
134d slower than avg
Panel avg: 115d · This submission: 249d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02635880 Completed Interventional Industry-sponsored

A Clinical Evaluation of a Novel Multi-Wavelength Laser for Benign Pigmented Lesion Removal

32
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Pigmented Skin Lesion of Suspected Benign Nature
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Lourdes Moldre, NP
Sponsor Cutera Inc. (industry)
Started 2015-09-01 → Primary completion 2016-02-01 → Completed 2016-03-23
Primary outcome
Percentage of Participants With Change of Treated Lesions
Secondary outcome
Percentage of Particpant Satisfaction of Improvement in Treated Lesions by the Subject
View full study on ClinicalTrials.gov

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 2216
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K160488.
Magma Spark
K162781 · Formatk Systems , Ltd. · Nov 2016
Lucid Q-PTP / HWA 55
K161670 · Bison Medical Co, Ltd. · Nov 2016
FRAXIS DUO
K160312 · Ilooda Co,., Ltd. · Oct 2016
EdgeOne CO2 Laser
K162169 · Jeisys Medical, Inc. · Oct 2016
NeuroBlate System
K162762 · Monteris Medical, Inc. · Oct 2016
Olive Plus
K161981 · Ama Network, Inc. · Oct 2016