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K Number
K050218
Device Name
WAVELIGHT SINON
Manufacturer
WAVELIGHT LASER TECHNOLOGIE AG
Date Cleared
2005-02-15

(15 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
K040433,K991285,K910422,K971814,K040384
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. 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.
  2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.
Device Description

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 = 10 °s) 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.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the WaveLight SINON laser system. It describes the device, its indications for use, and a comparison to predicate devices, but it explicitly states that no performance data is presented. Therefore, I cannot extract the requested information to describe acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document states:
"6. Performance Data
None presented."

This means that the document does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Information on experts or ground truth establishment.
  4. Adjudication methods.
  5. MRMC comparative effectiveness study results.
  6. Standalone performance data.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.