(90 days)
- In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
- In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.
The SINON is a 694 nm Ruby laser system which can be operated in two different modes. The quality-switch or Q-switch or QS Operating Mode is characterized by extremely short pulse widths (ns = 103s) and high peak power (MW = 106 W). The QS Operating Mode in the SINON is used for the removal of tattoos and treatment of pigmented lesions. The second mode is the Free-Running Operating Mode which is used for the removal of hair.
The provided document, K040433 for the WaveLight Laser Technologie, AG SINON laser system, does not contain information about acceptance criteria or a study proving the device meets them.
The document explicitly states "Performance Data None presented." in section 6. This means there are no details available within this submission regarding:
- Specific acceptance criteria for device performance.
- Any studies conducted to demonstrate the device meets such criteria.
- Sample sizes for test sets or their provenance.
- Information about experts, ground truth, or adjudication methods for any hypothetical test sets.
- Any multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Training set details or how their ground truth was established.
This 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices based on device description and intended use, rather than presenting detailed performance study data.
§ 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.