Cleared Traditional

K022466 - PROFILE 1320 LASER SYSTEM

K022466 is an FDA 510(k) clearance for PROFILE 1320 LASER SYSTEM, manufactured by Sciton, Inc. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K022466 · Sciton, Inc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
159d
Days
Class 2
Risk

K022466 is an FDA 510(k) clearance for the PROFILE 1320 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 December 31, 2002 after a review of 159 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

FDA 510(k) Submission Details - K022466

510(k) Number K022466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2002
Decision Date December 31, 2002
Days to Decision 159 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
44d slower than avg
Panel avg: 115d · This submission: 159d
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 1598
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K022466.
CANDELA SMOOTHBEAM LASER SYSTEM
K022884 · Candela Corp. · Jan 2003
VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
K023464 · Quantel Medical · Jan 2003
CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25
K024088 · Biolitec, Inc. · Jan 2003
NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160
K023962 · New Star Lasers, Inc. · Dec 2002
CANDELA GENTLE YAG LASER SYSTEM
K023193 · Candela Corp. · Dec 2002
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
K021548 · Fotona D.D. · Dec 2002