Cleared Traditional

K915000 - ACU-GUARD

K915000 is the FDA 510(k) clearance for ACU-GUARD by Acuderm, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K915000 · Acuderm, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 1992
Decision
81d
Days
Class 2
Risk

K915000 is an FDA 510(k) clearance for the ACU-GUARD. 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 Acuderm, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on January 27, 1992 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Acuderm, Inc. devices

Submission Details

510(k) Number K915000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1991
Decision Date January 27, 1992
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
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 1201
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K915000.
LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY
K912618 · Heraeus Lasersonics, Inc. · Feb 1992
EXCEL MODEL XLT-ONE ND:YAG LASER SYSTEM
K914849 · Excel Tech. , Ltd. · Feb 1992
LATERALASE
K915354 · Trimedyne, Inc. · Feb 1992
METAL ENCLOSED SIDE FIRING FIBERS
K915223 · Trimedyne, Inc. · Jan 1992
SIRIUS
K912813 · Pfizer Laser Systems · Dec 1991
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
K914952 · Trimedyne, Inc. · Dec 1991