Cleared Traditional

K130028 - RESURFX 1565NM LASER MODULE

K130028 is an FDA 510(k) clearance for RESURFX 1565NM LASER MODULE, manufactured by Lumenis, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code ONG cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K130028 · Lumenis, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
243d
Days
Class 2
Risk

K130028 is an FDA 510(k) clearance for the RESURFX 1565NM LASER MODULE. Classified as Powered Laser Surgical Instrument With Microbeamfractional Output (product code ONG), Class II - Special Controls.

Submitted by Lumenis, Ltd. (Binyamina, IL). The FDA issued a Cleared decision on September 3, 2013 after a review of 243 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 Lumenis, Ltd. devices

FDA 510(k) Submission Details - K130028

510(k) Number K130028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2013
Decision Date September 03, 2013
Days to Decision 243 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
128d slower than avg
Panel avg: 115d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ONG Device Classification - Class 2, Special Controls

Product Code ONG Powered Laser Surgical Instrument With Microbeamfractional Output
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. The Laser Output Is In Form Of Tiny Beams In Micro Range. Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic To Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue. 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.

Regulatory Consultant

Boston Scientific
Donna Gardner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 30
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