(72 days)
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.