Cleared Special

CONTOUR PROFILE LASER (K010285) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010285 · Sciton, Inc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
29d
Days
Class 2
Risk

K010285 is an FDA 510(k) clearance for the CONTOUR PROFILE 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 Sciton, Inc (Palo Alto, US). The FDA issued a Cleared decision on March 1, 2001 after a review of 29 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sciton, Inc devices

Submission Details

510(k) Number K010285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2001
Decision Date March 01, 2001
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K010285.
CYNOSURE PHOTOGENICA NEO-V
K004039 · Cynosure, Inc. · Mar 2001
INDIGO LASEROPTIC TREATMENT SYSTEM
K003952 · Ethicon Endo-Surgery, Inc. · Mar 2001
INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001
K003953 · Ethicon Endo-Surgery, Inc. · Mar 2001
CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER
K992757 · Cynosure, Inc. · Jun 2000
CYNOSURE PHOTOGENICA VLS-STAR
K000490 · Cynosure, Inc. · Mar 2000
CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL
K994427 · Cynosure, Inc. · Jan 2000