Cleared Traditional

K023547 - DIOLASE 980 D LASER SYSTEM

K023547 is an FDA 510(k) clearance for DIOLASE 980 D LASER SYSTEM, manufactured by American Dental Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K023547 · American Dental Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
176d
Days
Class 2
Risk

K023547 is an FDA 510(k) clearance for the DIOLASE 980 D LASER SYSTEM. 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 American Dental Technologies, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on April 15, 2003 after a review of 176 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 American Dental Technologies, Inc. devices

FDA 510(k) Submission Details - K023547

510(k) Number K023547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2002
Decision Date April 15, 2003
Days to Decision 176 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
61d slower than avg
Panel avg: 115d · This submission: 176d
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 1885
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K023547.
COOLTOUCH ND: YAG LASER SYSTEM
K030453 · New Star Lasers, Inc. · May 2003
SMARTXIDE
K031224 · Cynosure, Inc. · May 2003
ARAMIS II DERMATOLOGICAL LASER
K023734 · Quantel Medical · May 2003
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
K030147 · Lumenis, Ltd. · Apr 2003
POLRIS LV
K030186 · Syneron Medical, Ltd. · Apr 2003
CANDELA GENTLE LASE FAMILY OF LASER SYSTEM
K024371 · Candela Corp. · Mar 2003