Cleared Traditional

K001511 - O-LAS OPHTHALMIC PHOTODISRUPTOR

K001511 is an FDA 510(k) clearance for O-LAS OPHTHALMIC PHOTODISRUPTOR, manufactured by A.R.C. Laser AG. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K001511 · A.R.C. Laser AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
65d
Days
Class 2
Risk

K001511 is an FDA 510(k) clearance for the O-LAS OPHTHALMIC PHOTODISRUPTOR. 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 A.R.C. Laser AG (Salt Lake City, US). The FDA issued a Cleared decision on July 19, 2000 after a review of 65 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all A.R.C. Laser AG devices

FDA 510(k) Submission Details - K001511

510(k) Number K001511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2000
Decision Date July 19, 2000
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
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 2176
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K001511.
CERALAS D10 810NM LASER, MODEL CERALAS D10-60
K001975 · Ceram Optec, Inc. · Aug 2000
FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
K001527 · Fotona D.D. · Jul 2000
EPI-STAR SURGICAL LASER SYSTER
K990119 · Nidek, Inc. · Jul 2000
SURGILIGHT, INC EXCIMER LASER
K993328 · Surgilight, Inc. · Jul 2000
CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER
K992757 · Cynosure, Inc. · Jun 2000
LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM
K993154 · A.R.C. Laser Corp. · Jun 2000