Cleared Traditional

K001211 - MODIFICATION TO INTRALASE 600C LASER KERATOME

K001211 is an FDA 510(k) clearance for MODIFICATION TO INTRALASE 600C LASER KE..., manufactured by Intra Lase Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K001211 · Intra Lase Corp. · General & Plastic Surgery device
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Dec 2000
Decision
234d
Days
Class 2
Risk

K001211 is an FDA 510(k) clearance for the MODIFICATION TO INTRALASE 600C LASER KERATOME. 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 Intra Lase Corp. (Irvine, US). The FDA issued a Cleared decision on December 4, 2000 after a review of 234 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 Intra Lase Corp. devices

FDA 510(k) Submission Details - K001211

510(k) Number K001211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2000
Decision Date December 04, 2000
Days to Decision 234 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
119d slower than avg
Panel avg: 115d · This submission: 234d
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 1905
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K001211.
DENLASER, MODEL 800
K003541 · CAO Group, Inc. · Jan 2001
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210
K002308 · Trimedyne, Inc. · Dec 2000
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
K003147 · Laserscope · Dec 2000
SCITON IMAGE HAIR REMOVAL LASER
K002853 · Sciton, Inc · Dec 2000
PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES
K002884 · Fotona D.D. · Dec 2000
IMAGE VASCULAR LASER
K003046 · Sciton, Inc · Nov 2000