(90 days)
The Fotona Novalis Er: Y AG Laser System and Accessories are intended for surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue. All soft tissue is included, such as, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
DermatologyPlastic Surgery : epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacing, superficial skin lesions, and performing diagnostic biopsies.
General Surgery : surgical incision/excision, cutting, ablation, vaporization, and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated
Genitourinary : Jesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon
Gynecology : cerivecal intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma
Oral/Maxillofacial : benign oral tumors, oral and glossal lesions and gingivectomy
Otorhinolaryngology/Head and Neck (ENT) : ear, nose and throat lesions, polyps, cysts, lyperkeratosis, excision of carcinogenic tissue and oral leukoplakia
Ophthalmology : soft tissue surrounding the eye and orbit anterior capsulotomy
Podiatry : warts, plantar vernicae, large mosaic verrucae and matrixectorny
The Fotona Novalis Er. YAG system ia a microprocessor controlled device which generates lascr light with a wavelongth of 2940 nm when used in conjunction with a host Novelis R system. When combined, the Er. YAG accessory and the host Ruby system constitute the Novalis RE laser system.
The Fotona Er. Y AG system is designed as an accessory for use with the Fotona Novalis R laser system "The Fir Y A ( suh-system is fincrionally integrated to the host laser system. When integrated, the host laser system recognizes the presence of the accessory and permits activation of the 2940 nm pulsed light via the same touchscreen as the host Ruby
The Novalis Er. YAG system is designed with 3 major sub-systems:
d) An optical dclivery system, interfacing the cncrgy from the lascr to the patient via an articulated arm and a focusing or collimated handpiece.
b) An electronic power supply and interfsce circuitry.
c) An optical chamber containing laser rod and laser cavity optics.
Accessories available for use with the Fotona Novalis Er: Y AG:
- Fotona SkinScan Scanning Device .
The provided text describes a 510(k) submission for the Fotona Novalis Er: YAG laser system, seeking substantial equivalence to predicate devices. It does not contain any information regarding acceptance criteria or a study proving the device meets specific performance criteria.
The document is a regulatory submission for premarket notification to the FDA, focusing on establishing substantial equivalence for market clearance. It details the device's technical specifications and intended uses, comparing them to already cleared devices.
Therefore, I cannot provide the requested information. The text does not include:
- A table of acceptance criteria or reported device performance.
- Sample sizes for a test set, data provenance, number of experts, adjudication methods, or ground truth details for a performance study.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Sample sizes or ground truth establishment for a training set.
The document states that Fotona believes its Novalis system is "substantially equivalent" to two other laser systems (Laserscope Venus Erbium Laser System and Continuum Biomedical CB Erbium/2.94 Er: YAG Laser). The basis for this claim is that "Technologically, the predicate devices have identical characteristics to the Novalis Er: Y AG laser" and "The risk and benefits for the Fotona Novalis are comparable to the Laserscope Venus Laser System and Continuum Biomedical (Con-Bio) CB Erbium/2.94 Er: YAG Laser System when used for similar clinical applications."
This is a regulatory argument for substantial equivalence, not a detailed performance study with acceptance criteria and results.
§ 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.