(423 days)
Medical Diode Laser Systems are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery;debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions;papillectorny; vestibuloplasty ; excision of lesions; exposure of unerupted partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening: Medical Diode Laser Systems are indicated for light activation materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy: Medical Diode Laser Systems are intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffins pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
The Medical Diode Laser System is a compact, air-cooled unit. It is a complete self-contained instrument, which includes a high efficiency power supply, a microprocessor controlled, adjustable light output with automatic power stabilization, (fan cooled), as well as a switch panel and LCD screen display panel designed to be user friendly. The system includes high power lasers, safety features and an SMA fiber output connector. The system includes a Lithium battery, it can work 1hour when not external power input at maximum power output in pulse or CW but intermittent mode. The diodes are made from GaAlAs semiconductor material for high output and superior reliability. The diode lasers are enclosed in a rugged, factory-aligned, replaceable, environmentally protective module. High-capacity fans eliminate the need for water-cooling, and assure low maintenance and reliable laser operation. The diodes convert electric energy into coherent laser radiation with a wavelength of 810nm or 980nm+/-10nm (pilot beam: 650nm+/-10nm).
This document is a 510(k) premarket notification for a medical device (Medical Diode Laser Systems) and explicitly states that no clinical testing was performed. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully answered as it pertains to clinical performance and AI integration.
The provided document focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical testing (electrical safety, EMC, laser safety standards, and software verification). There is no mention of AI/ML, human-in-the-loop performance studies, or ground truth establishment based on expert consensus, pathology, or outcomes data, which are typical requirements for AI/ML device clearances.
Based on the provided text, here's what can be inferred/extracted and what cannot be answered:
1. Table of acceptance criteria and the reported device performance:
Since no clinical or AI performance study was presented, the "acceptance criteria" here refer to conformance with established safety and performance standards for laser medical devices.
| Acceptance Criteria (from Non-Clinical Tests) | Reported Device Performance (Compliance) |
|---|---|
| Conformity to IEC 60601-1 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) | Verified |
| Conformity to IEC 60601-1-2 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility) | Verified |
| Conformity to IEC 60825-1 (Safety of laser products - Part 1: Equipment classification and requirements) | Verified |
| Performance according to IEC 60601-2-22 (Medical electrical equipment Part 2: Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment). | Verified |
| Software Verification and Validation (for "moderate" level of concern) as per FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Conducted and documentation provided. |
| Device Specifications (Comparison to predicate, serving as a form of "performance" for equivalence) | (All stated as "Identical" or "Substantial Equivalence" to predicate/reference devices) |
| Product Code (NVK, GEX, ILY) | Identical (to predicate K210367) |
| Regulation Number (21 CFR 878.4810) | Identical |
| Classification (Class II) | Identical |
| Indications for Use | Substantial Equivalence (Proposed device's intended use is same as predicate; reference device does not have light activation for bleaching materials for teeth whitening, but this difference does not affect safety and effectiveness based on the submission.) |
| Application (Dental Laser) | Identical |
| Laser Classification (Class IV) | Substantial Equivalence (Predicate states 976nm and 450nm: Class IV, 650nm: Class II; Reference states Class IV). The document implies this is an acceptable difference for substantial equivalence. |
| Type of Laser (Diode Laser) | Identical |
| Wavelength (810 ± 10nm; 980 ± 10nm) | Substantial Equivalence (Predicate: 976nm, 650nm, 450nm; Reference: 810nm, 980nm). Stated that modification (different wavelengths) does not adversely affect safety and effectiveness. |
| Average Power (Range specific to models) | Similar to predicate/reference device. Example: Proposed DEN7A/DEN7B: 0.1W-7W vs. Predicate D-Laser Blue 976nm: 0.2W-4W (CW), 7W (peak). Reference: 0.1-2W, 20W (peak). The ranges for the proposed device generally align with or explain differences within the scope of the predicate devices. |
| Operation Mode (Continuous Wave; Pulse) | Identical to the predicate. |
| Pulse width (e.g., 1ms-1000ms for DEN models) | Similar (Predicate: 5 µsec. to 0.9 sec.; Reference: Variable). |
| Pulse repetition rate (e.g., 0.5Hz-500Hz for DEN models) | Similar (Predicate: 1 Hz—20 kHz; Reference: 50Hz). |
| Aiming Beam (650±10 nm, 5mw (max)) | Substantial Equivalence (Predicate: 650±20 nm, Pmax |
§ 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.