(36 days)
For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles.
The New Star CoolTouch® Nd:YAG Surgical Laser Systems are ND:YAG lasers producing laser emission at 1320 nm. The lasers consists of three interconnected sections: The cabinet which houses the power supply, the cooling system, the microcontroller and the laser, the fiber optics and the handpiece.
The provided text is a 510(k) Summary for a medical device, the "New Star Nd:YAG Surgical Laser Model CoolTouch® 3". It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document explicitly states "Performance Data: None".
Therefore, the following information cannot be provided from the given text:
- Acceptance criteria and reported device performance: No performance data is reported, and thus no acceptance criteria are mentioned.
- Sample size used for the test set and data provenance: No test set was used for performance evaluation.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth was established for performance evaluation.
- Adjudication method for the test set: No test set adjudication occurred.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was conducted.
- Standalone (algorithm only without human-in-the-loop performance) study: This device is a laser system, not an algorithm. No such study was conducted.
- Type of ground truth used: No ground truth was used for performance evaluation.
- Sample size for the training set: This device is a laser system, not an AI/ML algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The submission for the New Star Nd:YAG Surgical Laser Model CoolTouch® 3 relies on substantial equivalence to existing predicate devices (New Star Lasers, Inc. Model NS-130 (CoolTouch®) and Model CoolTouch® II Nd:YAG Laser Systems) rather than presenting new performance data or a study to meet specific acceptance criteria. The document explicitly states "Performance Data: None," indicating that no clinical or technical performance study was conducted or reported to define and meet specific acceptance criteria for this particular 510(k) submission.
§ 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.