(10 days)
The Smart US 20 D / UltraSpeed and Smart Clinic laser is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialities of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic liaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.
Also, the Smart CO2 surgical laser is indicated for periodontal applications such as, but not limited to:
Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement)
Biopsies
Frenectomy, Frenum release
Gingivoplasty
Papillectomy
Vestibuloplasty
Hyperplasia
Operculectomy
Drainage (abscess)
Flap surgery
Fibroma (nonmalignant tumor, mucosa, tongue)
Epulis
Aphthous ulcers
Removal of soft tissue, cysts, and tumors
Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
The PerioPulse laser is indicated for the removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement). It is also indicated for laser assisted new attachment procedure (cementum-medlated periodontal ligment new attachment to the root surface in the absence of long junctional epithelium)
Smart CO2 is a CO2 laser, having a sealed CO2 gas tube as the lasing medium. It is a laser with a wavelength of 10.6 um. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.
The provided 510(k) summary for the Cynosure Smart CO2 laser (K081181) states that no nonclinical or clinical performance data was provided. The submission relies on substantial equivalence to predicate devices (Lumenis OpusDent Family laser and Millennium Dental Technologies PerioLase Dental Laser) based on having the same principle of operation, essentially the same power range, and the same indications for use.
Therefore, the following information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from the provided document:
- A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are presented.
- Sample sizes used for the test set and the data provenance: No test set data exists.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is mentioned for a test set.
- Adjudication method: No adjudication method is mentioned as no study was conducted.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done: No such study was conducted.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a laser device, not an algorithm.
- The type of ground truth used: Not applicable as no study with ground truth was conducted.
- The sample size for the training set: Not applicable as no training set for an algorithm was used.
- How the ground truth for the training set was established: Not applicable.
In summary, the 510(k) submission for the Cynosure Smart CO2 laser did not include data from a clinical or nonclinical study to demonstrate its performance against specific acceptance criteria. Instead, it leveraged the concept of substantial equivalence to already legally marketed predicate devices.
§ 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.