Cleared Traditional

PROFILE 1064 LASER SYSTEM (K023881) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023881 · Sciton, Inc · General & Plastic Surgery device
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Jun 2003
Decision
204d
Days
Class 2
Risk

K023881 is an FDA 510(k) clearance for the PROFILE 1064 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 Sciton, Inc (Palo Alto, US). The FDA issued a Cleared decision on June 13, 2003 after a review of 204 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 Sciton, Inc devices

Submission Details

510(k) Number K023881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2002
Decision Date June 13, 2003
Days to Decision 204 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
89d slower than avg
Panel avg: 115d · This submission: 204d
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 633
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K023881.
CYNOSURE PHOTOLIGHT PL
K031258 · Cynosure, Inc. · Jul 2003
CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)
K031690 · Cynosure, Inc. · Jul 2003
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K030654 · Vascular Solutions, Inc. · Jun 2003
CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER
K031488 · Cynosure, Inc. · Jun 2003
SMART 2940 D ER: YAG LASER
K031317 · Cynosure, Inc. · May 2003
SMARTXIDE
K031224 · Cynosure, Inc. · May 2003