Cleared Traditional

enlighten III Laser System (K182997) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K182997 · Cutera, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
43d
Days
Class 2
Risk

K182997 is an FDA 510(k) clearance for the 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 December 12, 2018 after a review of 43 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cutera, Inc. devices

Submission Details

510(k) Number K182997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2018
Decision Date December 12, 2018
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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
NCT03284333 Completed Interventional Industry-sponsored

enLighten Laser With MLA Handpiece for Treatment of Moderate and Severe Acne Scars

Open-label, Prospective, Multicenter Study to Evaluate the Cutera enLighten™ Laser and a Micro-Lens Array Handpiece Attachment for the Treatment of Moderate and Severe Acne Scars

45
Patients (actual)
2
Sites
Other
Purpose
Open label
Masking
Condition studied Acne Scars - Mixed Atrophic and Hypertrophic
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Stephen Ronan, M.D.
Sponsor Cutera Inc. (industry)
Started 2017-07-27 → Primary completion 2018-09-05
Primary outcome
Correct Identification of the 12 Weeks Post-final Treatment Photographs From the Baseline Photographs by at Least 2 of the 3 Blinded Reviewers in 75% of the Patients.
View full study on ClinicalTrials.gov

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