(76 days)
The JENASCAN is intended for use as an accessory to surgical lasers, e.g., lasers used in dermatology and plastic surgery, for the ablation and vaporization of soft tissue under conditions of use as described in the manuals accompanying the lasers.
Please refer to the application, operator's, or user's manual(s) accompanying the laser for professional use instructions and detailed use information concerning the laser.
The Jenoptik JENASCAN is a microprocessor-controlled accessory for lasers used in dermatology and plastic surgery. The JENASCAN guides the laser energy over the skin during removal of soft tissue under the conditions of labeling as described in the laser operator's manual.
The provided document is a 510(k) summary for the JENOPTIK JENASCAN, a laser accessory. It explicitly states that no performance data were required or provided because the device is considered substantially equivalent to already legally marketed predicate devices. Therefore, the requested information regarding acceptance criteria, study details, and performance metrics cannot be extracted from this document.
The relevant section from the document states:
"Performance Data: None. The specifications and intended uses of the Jenoptik JENASCAN are the same or very similar to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."
§ 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.