(106 days)
The Spectra DENTA II Laser System is indicated for use in soft tissue dental indications including periodontic procedures such as, but not limited to, removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement), vaporization, gingivectomy-removal of hyperplasias, gingivoplasty, papillectomy, vestibuloplasty, fibroma (nonmalignant tumor, mucosa, tongue), epulis, incision and excision, removal of soft tissue, cysts, and tumors, and laser assisted new attachment procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium); Oral surgery such as frenectomy, frenum release, drainage (abscess), flap surgery, incisional and excisional biopsy, incision and excision of aphthous ulcers, incision of infection when used with antibiotic therapy, excision and ablation of benign and malignant lesions, oral cavity tumors and hemangiomas, salivary gland pathologies, preprosthetic gum preparation, leukoplakia; partial glossectomy, periodontal gum resection, homeostasis, operculectomy, and crown lengthening.
The Spectra SP II Laser System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, (knee), and open endoscopic general surgery.
The Spectra DENTA II and Spectra SP II Laser Systems are identical CO2 laser systems supplied with different handpieces depending upon the indications for use. They consist of a self-contained console, an articulated arm delivery system, a footswitch and a pair of goggles. The Spectra DENTA II and Spectra SP II Laser Systems produce a beam of coherent infrared (10.6um) light and have Continuous Wave, Char-Free and Super Pulse operation modes.
The main console is the heart of the Spectra DENTA II and Spectra SP II Laser Systems and contain the optical system (with DC-Excited Sealed-off Carbon Dioxide gas tube), cooling system, arm mount, micro-controller, and power supply. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the control panel. There are 4 casters in the console base for moving the system.
The laser beam exits an articulated arm into a handpiece where it is focused by the final focus lens contained in the handpiece to produce a spot size at the treatment focal plane. The handpiece components, when inserted in the beam delivery system, change the laser beam characteristics. Different handpieces are provided with the Spectra DENTA II and the Spectra SP II depending upon the desired indications for use.
The provided document is a 510(k) summary for the Lutronic Corporation Spectra DENTA II/Spectra SP II Laser Systems. Crucially, the document explicitly states "Performance Data None presented." This means that no studies proving the device meets specific acceptance criteria were submitted or are detailed within this summary.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for either a test set or training set, as this information is not present in the provided text.
The document focuses on:
- General Information: Submitter, contact person, date, device names, classification.
- Predicate Devices: Listing previously cleared devices to which the current device is deemed substantially equivalent.
- Device Description: Physical characteristics and operational modes of the laser systems.
- Indications for Use: A detailed list of medical specialties and specific conditions for which the Spectra DENTA II and Spectra SP II Laser Systems are intended to be used.
- FDA Correspondence: Official FDA letter confirming the review and determination of substantial equivalence, along with regulatory information.
§ 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.