Cleared Traditional

K032846 - SPECTRA PULSED DIODE LASER, MODEL DR-1

K032846 is an FDA 510(k) clearance for SPECTRA PULSED DIODE LASER, manufactured by Spectragenics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K032846 · Spectragenics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
91d
Days
Class 2
Risk

K032846 is an FDA 510(k) clearance for the SPECTRA PULSED DIODE LASER, MODEL DR-1. 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 Spectragenics, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 11, 2003 after a review of 91 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.

FDA 510(k) Submission Details - K032846

510(k) Number K032846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2003
Decision Date December 11, 2003
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
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 2810
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K032846.
CLINICAL LASETTE P-200
K033799 · Cell Robotics, Inc. · Dec 2003
YA-MAN LASER 21
K032944 · Ya-Man, Ltd. · Dec 2003
RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY
K032205 · Radiancy (Israel) , Ltd. · Dec 2003
MODIFICATION TO AURORA DS
K033586 · Syneron Medical, Ltd. · Dec 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K030834 · Candela Corp. · Dec 2003
SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM
K032735 · Max Engineering , Ltd. · Dec 2003
K032846 · SPECTRA PULSED DIODE LASER, MODEL DR-1
Download PDF FDA Summary Spectragenics, Inc.