(10 days)
The CoolTouch Model LC225/CoolTouch CoolLipo Nd:YAG Surgical Laser is indicated for the following:
a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue;
b) for use in the treatment of fine lines and wrinkles;
c) for treatment of back acne and atrophic acne scars;
d) for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and;
e) for laser-assisted lipolysis.
The LC225/CoolLipo Nd:YAG Laser System produces laser emission at 1320nm. The laser 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 or JouleTracker
The provided text is a 510(k) summary for the CoolTouch LC225/CoolTouch CoolLipo Nd:YAG Laser System. It indicates that the device is substantially equivalent to a predicate device (CoolTouch LC215/CoolTouch CoolLipo Nd:YAG Laser System) and was cleared without specific performance data, clinical studies, or an AI component.
Therefore, the following information cannot be extracted from the given text:
- A table of acceptance criteria and the reported device performance: No specific performance criteria or results are mentioned.
- Sample size used for the test set and the data provenance: No test set information is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is not an AI-assisted device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable as this is not an AI device.
- How the ground truth for the training set was established: Not applicable.
Explanation from the document:
The "Performance Data" section in the K081628 summary explicitly states "None." This indicates that no specific studies demonstrating performance criteria or safety/effectiveness were conducted or provided as part of this 510(k) submission. The conclusion states: "Based on the evaluation of the risks and hazards and including various testing of the modifications, the CoolTouch LC225/CoolLipo Nd:YAG Surgical Laser System is substantially equivalent to the predicate device, the LC215." This implies that the device achieved market clearance based on its similarity to an already legally marketed predicate device, rather than through new performance studies with acceptance criteria.
§ 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.