Cleared Traditional

K011092 - CANDELA SPTL-1E PULSED DYE LASER

K011092 is an FDA 510(k) clearance for CANDELA SPTL-1E PULSED DYE LASER, manufactured by Candela Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K011092 · Candela Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
90d
Days
Class 2
Risk

K011092 is an FDA 510(k) clearance for the CANDELA SPTL-1E PULSED DYE 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 Candela Corp. (Wayland, US). The FDA issued a Cleared decision on July 9, 2001 after a review of 90 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 - K011092

510(k) Number K011092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2001
Decision Date July 09, 2001
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 2870
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K011092.
INPULSE DENTAL LASER
K011423 · Incisive, LLC · Aug 2001
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
K011382 · Photo Medex, Inc. · Aug 2001
LASER PERIPHERALS REUSABLE HOLMIUM FIBER
K011207 · Laser Peripherals, LLC · Jul 2001
WATERLASE, MILLENNIUM
K011041 · Biolase Technology, Inc. · Jul 2001
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER
K011677 · Continuum Electro-Optics, Inc. · Jun 2001
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
K010927 · Medical Bio Care Sweden AB · Jun 2001
K011092 · CANDELA SPTL-1E PULSED DYE LASER
Download PDF FDA Summary Candela Corp.