(247 days)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue. The device is intended for use in the following procedures: 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, Leukoplakia, Exposure of Unerupted / Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
The Orion laser system is a pulsed and cw diode laser emitting a wavelength of 980 nm, that is intended for ablating, excising and coagulation of intraoral soft tissue using a contact fiber optical delivery system.
The provided 510(k) summary for the ASCLEPION LASER TECHNOLOGIES GmbH Orion laser system explicitly states:
Nonclinical Performance Data: None
Clinical Performance Data: None
Therefore, no acceptance criteria, study details, or performance data are provided in this document. The device did not undergo performance testing to demonstrate its safety and effectiveness. Instead, its substantial equivalence to a predicate device (GENTLEray 980 K072262) was established based on having the "same principles of operation, with the same parameters and with the same indications for use."
§ 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.