(97 days)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
Indications for use are the following applications: marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy frenotomy, biopsy, operculectomy, Implant recovery, gingivectomy, gingivoplasty, gingival troughing crown lengthening, hemostasis of donor site removal of granulation tissue, laser assisted flap surgery debridement of deseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphthous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy.
The SIROLaser Advance is a Diode Laser System for dental soft tissue surgery. The system is comprised of the laser unit with handpiece, laser fibers of different diameters, bendable tips, and a wireless foot control.
The SIROLaser Advance has the following basic functions
- Ability to emit laser radiation either in continuous wave mode (cw) or . chopped mode
- Setup and display of treatment parameters: .
- o power,
- o treatment time,
- chop frequency o
- o duty cycle
- Selection of predetermined settings for different indications ●
- Upgradeable firmware .
This document describes the Sirona Dental Systems SIROLaser Advance, a diode laser system for dental soft tissue surgery, and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert ground truth establishment, or clinical performance metrics as requested in your prompt.
The 510(k) summary primarily focuses on:
- Identification of the device: SIROLaser Advance
- Intended Use: Various intra- and extra-oral soft tissue surgical applications.
- Predicate Devices: SIROLaser, Kavo Gentle Ray 980, Ivoclar Odyssey Navigator, Ceramoptec Ceralas D15.
- Device Description: Functions include continuous/chopped wave modes, parameter setup, predetermined settings, and upgradeable firmware.
- Basis for Substantial Equivalence: Stated as performance testing for electrical safety, electromagnetic compatibility, and validation of hardware and software functions.
Therefore, I cannot fulfill your request for the tables and specific details regarding acceptance criteria, study methodologies, sample sizes, and expert qualifications, as this information is not present in the provided text.
The document is a 510(k) summary which claims substantial equivalence based on in vitro engineering and safety testing, not clinical performance studies with human subjects or a comparison of AI assistance. It falls under the regulatory pathway for medical devices (Class II) where performance is often demonstrated through engineering testing and comparison to existing devices, rather than clinical efficacy trials that would typically involve the detailed study design elements you've asked about.
§ 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.