(94 days)
Enamel Pure LUNE PureHygiene is indicated for the following in dental hard tissue:
• Reduction of bacterial level (decontamination)
The subject LUNE PureHygiene is a mobile, cart-based dental treatment system comprised of a base console, a pneumatic footswitch, and handpieces that uses a pulsed CO2 laser energy to reduce/remove plaque and embedded carbonate from dental enamel.
The provided text does not contain detailed information about acceptance criteria for a device, nor does it describe a study that proves a device meets specific acceptance criteria in the manner requested.
The document is an FDA 510(k) clearance letter for the LUNE™ PureHygiene dental laser system. It states that the device is substantially equivalent to a predicate device (Epic Pro/Hygiene Biolase). The "Summary of Performance Data (Nonclinical and/or Clinical)" section on page 5 lists non-clinical tests performed (Electrical Safety, EMC, Laser Safety, Software V&V, Design Verification, Reprocessing Validation, Biocompatibility Assessment) but explicitly states "N/A" for "Clinical Tests."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as no clinical study or specific performance acceptance criteria are detailed in this document.
The document primarily focuses on regulatory clearance based on substantial equivalence to existing devices, supported by non-clinical testing.
§ 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.