Cleared Traditional

CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 (K091125) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091125 · Verilux · General & Plastic Surgery device
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Sep 2010
Decision
504d
Days
Class 2
Risk

K091125 is an FDA 510(k) clearance for the CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2. Classified as Powered Light Based Non-laser Surgical Instrument (product code ONE), Class II - Special Controls.

Submitted by Verilux (South St. Paul, US). The FDA issued a Cleared decision on September 3, 2010 after a review of 504 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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Submission Details

510(k) Number K091125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2009
Decision Date September 03, 2010
Days to Decision 504 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
389d slower than avg
Panel avg: 115d · This submission: 504d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.