Cleared Traditional

K894471 - SURGIPROBES AND SURGISCALPES IN HEAD/NE...

K894471 is the FDA 510(k) clearance for SURGIPROBES AND SURGISCALPES IN HEAD/NE... by Surgilase, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K894471 · Surgilase, Inc. · General & Plastic Surgery device
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Nov 1989
Decision
119d
Days
Class 2
Risk

K894471 is an FDA 510(k) clearance for the SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY. 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 Surgilase, Inc. (Warwick, US). The FDA issued a Cleared decision on November 14, 1989 after a review of 119 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 Surgilase, Inc. devices

Submission Details

510(k) Number K894471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date November 14, 1989
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
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 737
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K894471.
SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM
K900077 · Sharplan Lasers, Inc. · Mar 1990
SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY
K896762 · Sharplan Lasers, Inc. · Feb 1990
SHARPLAN 1030 SEALED CO2 SURGICAL LASER SYSTEM
K896847 · Sharplan Lasers, Inc. · Jan 1990
SHARPLAN MODEL 710 MICROSPOT
K895746 · Sharplan Lasers, Inc. · Oct 1989
NIDEK MODEL ADC-8000
K894709 · Nidek, Inc. · Oct 1989
SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERY
K895042 · Sharplan Lasers, Inc. · Sep 1989