(35 days)
The CoolTouch Model LC215 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, and; d) for treatment of reflux of the great and small saphenous veins associated with varietse veins and varicosities.
The LC215 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 CoolTouch LC215 Nd:YAG Laser System is a surgical laser device. The provided documents focus on its substantial equivalence to a predicate device rather than on performance studies with specific acceptance criteria. Therefore, most of the requested information about device performance and studies is not available in these documents.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The submission is a 510(k) Pre-market Notification, which primarily establishes substantial equivalence to a legally marketed predicate device (CoolTouch CT3S Nd:YAG Laser System). It does not present specific performance criteria or a study demonstrating the device meets those criteria. The document explicitly states "Performance Data: None".
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No performance study data is presented for a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No performance study data is presented for a test set requiring ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable. No performance study data is presented for a test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The documents do not mention an MRMC comparative effectiveness study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical laser system, not an algorithm, so standalone performance in this context is not relevant.
7. Type of Ground Truth Used
Not applicable. No performance study data is presented for a test set requiring ground truth. The submission relies on demonstrating substantial equivalence to a predicate device for safety and effectiveness.
8. Sample Size for the Training Set
Not applicable. No machine learning or algorithmic training set is mentioned as this is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No machine learning or algorithmic training set is mentioned.
§ 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.