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Laser-assisted Bleaching/Whitening of the teeth. Illumination purposes for the adjunctive use in caries detection and endodontic orifice location. Curing of all light sensitive bonding materials including: Pit and fissure sealants, composite restorations, endodontic composite cores, composite cements for porcelain facings and inlays, periodontal splint material, and prosthetic reline and repair material.

The Dental 200, 300, & 400 Laser Systems are an instrument used in the application of Dentistry. With a level of output power of up to 10.0 Watts on some models, and the selectable blue or green wavelengths, additional indications for use are warranted. The use of these dental laser devices are supported by a line of FiberFlex™ Fibers in sizes of; 200, 300, 400, & 600 microns. Cannulas specifically designed for use in Dentistry and as companion to the bare fibers. The primary energy output source is an Argon Ion laser head for delivery to the patient. The selectable laser wavelength colors of green (treat) and blue (cure). This system has similar timing features for interval, and duration. The Aiming Beam is a visible Red Diode @ 630-680nm.

This document is a 510(k) premarket notification for the Dental 200, Dental 300, and Dental 400 Argon Laser Systems. It establishes substantial equivalence by comparing the submitted devices to predicate devices. As such, it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not on proving new performance claims against defined criteria through a study.

Therefore, I cannot provide the requested information from this document. Here's why:

1. Acceptance criteria and reported device performance: This document describes the functional characteristics of the device and compares them to predicate devices, but it does not specify quantitative acceptance criteria (e.g., "device must achieve X % accuracy") or report performance data against such criteria.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and ground truth for training set: These are all elements typically found in a clinical study report or performance validation report, which are not part of this 510(k) summary. The summary focuses on design and functional similarity to predicates.

In a 510(k) submission, the "study" that proves the device meets acceptance criteria is often a bench testing comparison to a predicate device or analysis of existing literature about the predicate device's performance, rather than a de novo clinical trial with specific performance endpoints. The "acceptance criteria" are implied by the performance of the predicate device.

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See attachment "B" for a complete listing of indicated uses (applied for).

Ophthalmology: (Atlas-Elite, Elite Ultra)

• Retinal Photocoagulation
• Trabeculoplasty
• Iridotomy
• Diabetic Retinopathy
• Peripheral Iridectomy
• Posterior and Anterior procedures

Ear, Nose, & Throat (ENT): (Atlas-Elite, Elite Ultra)

• Stapedectomy
• Stapedotomy
• Myringotomies
• Lysis of Adhesions
• Control of Bleeding
• Removal of Acoustic Neuromas
• Soft Tissue Adhesion in Micro/Macro Otologic procedures
• (Elite Ultra [4.0 Watt] only)
• Epistaxis (HHT)
• Partial Turbinate Reduction
• Vaporization/Coagulation of Granulation Tissue
• Photocoagulation or Vaporization of Soft or Fibrous Tissue

Dermatology: (Atlas-Elite, Elite Ultra, Corium 200, & Corium 400)

• Pigmented Lesions, inc. solar lentigines
• Vascular Lesions, inc. cherry hemangiomas & angiokeratomas
• Extremities Telangiectasias, inc. facial & leg telangiectasias
• Cutaneous Lesions
• Flat Warts
• Dermatosis
• Papulosa Nigra

Dentistry (Corium 200, Corium 400)

• Frenectomy
• Treatment of Oral Mucous Cysts
• Treatment of Benign Vascular Lesions:
• Capillary Hemangioma
• Hemorrhagic Hereditary Telangiectasia
• Capillary/Cavernous Hemangiomas
• Lymphongioma
• AV Malformation of the Tongue
• Hemanqiolymphangiomas
• Photocoagulation of Superficial Vessels
• Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels
• Treatment of Superficial Tonque Lesions
• Tissue Management and Hemostasis for Crown and Bridge Impressions
• Incision and Drainage for Abscess
• Gingivoplasty/Gingivectomy:
• Operative Procedures
• Crown and Bridge, Gingival Retraction
• Crown Lengthening
• Hyperplasia (Drug, Irritation, Epulis, ... )
• Hemostasis during Dental Procedures
• Operculectorny (Operculotomy)
• Excisional Biopsy
• Free Gingival Graft (Adjunct):
• Hemostasis of Donor Site
• Hemostasis of Graft Site
• Vestibuloplasty
• Soften Gutta Percha
• Treatment of Canker Sores, Herpetic Lesions, and Aphthous Ulcers
• Laser-assisted bleaching/whitening

The Diode Frequency Doubled Green Nd:YAG Surgical Laser System is an instrument used in the application of Photothermolysis (Photocoagulation) of soft tissue using a 532 nm wavelength. The laser light is produced by diode technology. With a higher level of output power of up to 10.0 Watts on future models, additional indications for use are warranted. Indications for use are supported by a line of collimated handpieces with spot sizes of: 200, 400, 600, 800, and 1200 microns, as well as, Slit Lamps (M-140 & M-150), Slit Lamp Attachments, (M-100 & M-101), Indirect Ophthalmoscopes, and Microfilters (Fixed and Moving).

The Elite Family's primary energy output source is a Diode Pumped Nd: YAG Rod, Frequency Doubled using a KTP crystal to a visible green 532 nm laser light for the delivery to the patient and treatment. This system has various timing features for interval, and duration. The Aiming Beam is a Visible Red Diode @ 620-640 nm wavelength.

The provided text is a K990174 510(k) summary for the Elite Family of Lasers. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria through performance metrics.

Instead, the document focuses on:

• Rationale for Substantial Equivalence: Comparing the Elite Family of Lasers with existing predicate devices (Iris Medical Instruments, Inc., DioLite 532 Laser System; Continuum Biomedical Inc., CB Diode/532 Laser System; Laserscope, Aura KTP 532/Green) based on similar indications for use, design features (wavelengths, beam integrity, cooling type), control systems (interlock devices, displays), and functional features (delivery power, pulse rates, energy type, spot sizes).
• Description of Submitted Device: Explaining the Diode Frequency Doubled Green Nd:YAG Surgical Laser System, its 532 nm wavelength, diode technology, output power, and compatible handpieces/accessories.
• Technological Characteristics: Detailing the Elite Family's energy source (Diode Pumped Nd: YAG Rod, Frequency Doubled using a KTP crystal to 532 nm) and comparing it to the predicate devices, highlighting similarities in wavelength, power, spot sizes, and pulse durations.
• Intended Uses: Listing a range of intended uses across Ophthalmology, Ear, Nose, & Throat (ENT), Dermatology, and Dentistry.

Therefore, based on the provided text, I cannot answer the questions about acceptance criteria, device performance tables, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set information.

This type of submission (510(k)) is primarily focused on demonstrating equivalence to existing devices rather than presenting the results of clinical performance studies with specific statistical acceptance criteria. While predicate devices would have undergone testing to establish their safety and effectiveness, this document does not detail individual performance metrics or a study conducted to meet specific acceptance criteria for the Elite Family of Lasers itself, beyond the general comparison to predicates.

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Ask a specific question about this device