Cleared Traditional

K120926 - ENDOBEAM HOLMIUM LASER FIBERS

K120926 is an FDA 510(k) clearance for ENDOBEAM HOLMIUM LASER FIBERS, manufactured by C.R. Bard, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K120926 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
122d
Days
Class 2
Risk

K120926 is an FDA 510(k) clearance for the ENDOBEAM HOLMIUM LASER FIBERS. 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 C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on July 27, 2012 after a review of 122 days - within the typical 510(k) review window.

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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K120926

510(k) Number K120926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2012
Decision Date July 27, 2012
Days to Decision 122 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
7d slower than avg
Panel avg: 115d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 Peers - GEX Powered Laser Surgical Instrument

All 1955
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K120926.
PRECISE SHP DIODE LASER
K113472 · CAO Group, Inc. · Aug 2012
MEDILAS H RFID LASER FIBER
K121938 · Dornier Medtech America, Inc. · Aug 2012
ORION
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ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
K120377 · J. Morita USA, Inc. · Jul 2012
WAVELIGHT FS200 PATIENT INTERFACE 1505
K121031 · Alcon Research, Ltd. · Jun 2012
PALOMAR VECTUS LASER
K120622 · Palomar Medical Technologies, Inc. · May 2012