(116 days)
The Cutera GenesisPlus Nd:YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic.laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary.thoracic surgery, podiatry and urology for surgical and aesthetic applications.
Dermatology:
The Cutera GenesisPlus laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosacea/ diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloid scars), and warts.
The Cutera GenesisPlus laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The GenesisPlus laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy
- Periungual and subungual warts
- Plantar warts
- Radical nail excision
- Neuromas
The Cutera GenesisPlus laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.).
The Cutera GenesisPlus Laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of a handpiece using a fiber optic delivery system with an optical lens at the aperture. The user activates laser emission by means of a footswitch.
The Cutera GenesisPlus Laser is designed to provide laser energy for use in a variety of dermatology and podiatry procedures.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies for the Cutera GenesisPlus Laser System:
Summary of Findings:
The provided document, a 510(k) Summary for the Cutera GenesisPlus Laser System, explicitly states "Performance Data: None" and "Results of Clinical Study: None." This means that traditional acceptance criteria based on clinical performance metrics and their verification through clinical trials are not presented in this summary.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. This regulatory pathway allows new devices to be marketed without new clinical trials if they are demonstrated to be as safe and effective as a legally marketed device (the predicate). The acceptance criteria in this context are primarily based on the technological characteristics being comparable to the predicate devices and the indications for use being similar.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the provided document does not contain an "acceptance criteria" table in the traditional sense of clinical performance metrics. The "performance" being demonstrated here is the device's technological equivalence to predicate devices.
| Feature/Criterion (Based on Predicate Equivalence) | Cutera GenesisPlus Laser Performance |
|---|---|
| Wavelength | 1064nm Nd:YAG |
| Aiming Beam | 630-680nm (≤ 2.5mW) |
| Energy per Pulse | 20-3500 mJ |
| Fluence | ≤ 25.5 J/cm² (with 1mm spot) |
| Max Power | ≤ 100W |
| Pulse Duration | 100 - 3000μs |
| Spot Size | 1mm (Podiatry), Up to 13mm (other indications) |
| Output Mode | Pulsed |
| Repetition Rate | 5 - 100 Hz |
| Laser Media | Flashlamp pumped solid state rod |
| User Interface | LCD color touchscreen |
| Indications for Use (General & Specific) | Equivalent to predicate devices (as detailed in the document) |
| Technological Characteristics | Equivalent to predicate devices |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is the 510(k) submission itself, which demonstrates substantial equivalence to "PinPointe Footlaser K09354 and K093545" and "Cutera Nd:YAG Laser K0222226." The core of this "proof" is a comparison of technological specifications and intended uses, rather than a clinical performance study. The conclusion explicitly states: "The Cutera GenesisPlus Laser is substantially equivalent in terms of indication for use and technology based on technical characteristics."
Detailed Responses to Specific Questions:
- A table of acceptance criteria and the reported device performance:
- Addressed in the table above. The "acceptance criteria" are implied by the features of the predicate devices against which technological equivalence is being claimed.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. The document explicitly states "Performance Data: None" and "Results of Clinical Study: None." Therefore, there was no test set of patients/data in a clinical study to establish performance metrics. The data provenance and sample size for such a test set are irrelevant in this specific 510(k) submission for this device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. As no clinical study results or performance data are presented, there was no "test set" requiring ground truth established by experts.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or clinical study was conducted, so no adjudication method was used or is described.
- 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. This device is a laser system, not an AI-assisted diagnostic tool or an imaging device requiring human readers or AI. Therefore, an MRMC study is not relevant to this submission.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser system and does not involve an algorithm working in a standalone capacity.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. There was no clinical study or test set for which ground truth was established, as the submission relies on substantial equivalence based on technological characteristics and intended use.
- The sample size for the training set:
- Not applicable. No clinical study data (or any other form of data for training purposes in the context of performance) is mentioned as being used for this 510(k) submission.
- How the ground truth for the training set was established:
- Not applicable. No training set or ground truth for it is mentioned in this 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.