Cleared Traditional

K912029 - ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL ...

K912029 is the FDA 510(k) clearance for ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL ... 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 98-day FDA review.

K912029 · Coherent Medical Group · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
98d
Days
Class 2
Risk

K912029 is an FDA 510(k) clearance for the ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER. 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 August 13, 1991 after a review of 98 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 Coherent Medical Group devices

Submission Details

510(k) Number K912029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1991
Decision Date August 13, 1991
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
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 K912029.
SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER
K912792 · Sharplan Lasers, Inc. · Aug 1991
LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER
K911830 · Laserscope · Aug 1991
LUXUS 132 ND: YAG SURGICAL LASER SYSTEM
K911987 · Heraeus Lasersonics, Inc. · Aug 1991
LATERALASE TM
K903418 · Trimedyne, Inc. · Jun 1991
CROSSFIRE LASER ASSISTED ASPIRATION CANNULA
K911408 · Heraeus Lasersonics, Inc. · Jun 1991
CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL.
K910496 · Heraeus Lasersonics, Inc. · May 1991