(23 days)
The Cynosure Apogee-TKS II laser is indicated for permanent hair reduction and the treatment of vascular lesions, pigmented lesions and wrinkles.
The Cynosure Apogee-TKS II Dermatological Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. It is used for all skin types (Fitzpatrick I - VI) including tanned skin.
It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
Cynosure Apogee-TKS II laser, having an Alexandrite crystal rod as the lasing medium. It is a laser with a wavelength of 755nm.
Laser activation is by either finger or foot switch. Overall weight of the laser is 45 Kg, and the size is 113x53x84 cm (HxWxD).
Electrical requirement is 230 VAC, 50A, 50-60 Hz, single phase.
The provided 510(k) summary for the Cynosure Apogee-TKS II Laser does not contain any information about acceptance criteria or a study proving the device meets them.
Instead, the submission states:
- Clinical Performance Data: none
- Nonclinical Performance Data: none
This indicates that the device was cleared based on its substantial equivalence to a predicate device (Cynosure Apogee-TKS) without new clinical or non-clinical performance studies being submitted or required. Therefore, I cannot provide the requested information.
The FDA's letter further confirms this by stating: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
In summary, the provided document does not contain the study details, acceptance criteria, or performance data typically associated with a new device demonstrating efficacy and safety through clinical or non-clinical trials.
§ 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.