Cleared Traditional

LASER PERIPHERALS REUSABLE HOLMIUM FIBER (K011207) - FDA 510(k) Clearance

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

K011207 · Laser Peripherals, LLC · General & Plastic Surgery device
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Jul 2001
Decision
96d
Days
Class 2
Risk

K011207 is an FDA 510(k) clearance for the LASER PERIPHERALS REUSABLE HOLMIUM FIBER. 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 Laser Peripherals, LLC (Golden Valley, US). The FDA issued a Cleared decision on July 24, 2001 after a review of 96 days - within the typical 510(k) review window.

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 Laser Peripherals, LLC devices

Submission Details

510(k) Number K011207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2001
Decision Date July 24, 2001
Days to Decision 96 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 115d · This submission: 96d
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 537
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K011207.
EDWARDS E360 SURGICAL ABLATION DEVICE
K041739 · Edwards Lifesciences, LLC · Sep 2004
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS
K023182 · Ethicon Endo-Surgery, Inc. · Oct 2002
INDIGO OPTIMA LASER SYSTEM
K013493 · Ethicon Endo-Surgery, Inc. · Dec 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
FUTURELASE 3000/3002 ERBIUM LASER SYSTEM
K974641 · Buckman Co., Inc. · Jun 1998