Cleared Traditional

K914991 - VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM S...

K914991 is the FDA 510(k) clearance for VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM S... by Coherent Medical Group. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K914991 · Coherent Medical Group · General & Plastic Surgery device
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May 1992
Decision
181d
Days
Class 2
Risk

K914991 is an FDA 510(k) clearance for the VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS. 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 Coherent Medical Group (Palo Alto, US). The FDA issued a Cleared decision on May 6, 1992 after a review of 181 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 Coherent Medical Group devices

Submission Details

510(k) Number K914991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1991
Decision Date May 06, 1992
Days to Decision 181 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 1181
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K914991.
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS.
K920062 · Candela Laser Corp. · Jun 1992
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SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE
K921596 · Sharplan Lasers, Inc. · May 1992
ANGLED DELIVERY DEVICE
K920589 · Laserscope · Apr 1992
HALOCATH LASER CATHETERS
K920934 · Trimedyne, Inc. · Apr 1992
ORION
K910152 · Pfizer Laser Systems · Apr 1992