Cleared Traditional

K171055 - Philips BlueControl

K171055 is an FDA 510(k) clearance for Philips BlueControl, manufactured by Philips Electronics Nederland B.V.. The device is a Class 2 General & Plastic Surgery device with product code ONE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K171055 · Philips Electronics Nederland B.V. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
87d
Days
Class 2
Risk

K171055 is an FDA 510(k) clearance for the Philips BlueControl. Classified as Powered Light Based Non-laser Surgical Instrument (product code ONE), Class II - Special Controls.

Submitted by Philips Electronics Nederland B.V. (Eindhoven, NL). The FDA issued a Cleared decision on July 6, 2017 after a review of 87 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.

FDA 510(k) Submission Details - K171055

510(k) Number K171055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2017
Decision Date July 06, 2017
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

ONE Device Classification - Class 2, Special Controls

Product Code ONE Powered Light Based Non-laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Light Based Non-laser Device Typically Indicated To Be Used 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. 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. 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
NCT02004847 Completed Interventional Industry-sponsored

Blue Light for Treating Psoriasis Vulgaris

Monocenter, Randomized, Double Blinded, Intraindividual, Exploratory Study of Effectiveness and Safety of 3 Months Treatment With 2 Peak Intensities of 453nm Blue Light for the Treatment of Mild Plaque Type Psoriasis Vulgaris

47
Patients (actual)
1
Site
Treatment
Purpose
Triple
Masking
Condition studied Psoriasis Vulgaris
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Verena von Felbert, PD, Dr.
Sponsor Philips Electronics Nederland BV (industry)
Started 2013-09-01 → Primary completion 2014-05-01
Primary outcome
Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity (HI) Group) as Compared to the Control Area at End of Treatment (Visit 7, Week 12).
Secondary outcome
Change From Baseline of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Treatment During the Attack Period (Week 4, Visit 5)
View full study on ClinicalTrials.gov

Regulatory Peers - ONE Powered Light Based Non-laser Surgical Instrument

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K171055 · Philips BlueControl
Download PDF FDA Summary Philips Electronics N…