(87 days)
The family of Fotona DUALIS Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology:
- To effect stable long-term, or permanent, hair reduction in skin types I VI through . selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a longterm stable reduction in the number of hairs regrowing after a treatment regimen.
- For removal of unwanted hair. ◆
- For coagulation and hemostasis of vascular lesions.
- For incision/excision of soft body tissue in dermatology .
- For soft tissue general surgery applications skin incision, tissue dissection; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation
The family of Fotona Dualis systems is based on the Nd: YAG laser technology. Within the systems, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming bearns are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.
The provided document is a 510(k) summary for the Fotona DualisXP, DualisVP, and Twinlight Nd:YAG Laser Systems. It establishes substantial equivalence to previously marketed devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy.
The document focuses on:
- General Information: Device trade names, common name, classification.
- Description: How the laser system works (Nd:YAG technology, flashlamps, optical cavity, fiber delivery, aiming beam).
- Intended Use: Surgical and aesthetic applications, including permanent hair reduction in Fitzpatrick skin types I-VI, removal of unwanted hair, coagulation/hemostasis of vascular lesions, and soft tissue incision/excision.
- Summary of Substantial Equivalence: Comparing the described device to predicate devices (Laserscope Lyra K010834 and Altus Medical Aesthetic Nd:YAG Laser K003202) based on technological characteristics (e.g., flashlamp pumped Nd:YAG, 1064 nm wavelength, fiber delivery, Class I aiming beams, microprocessor control, internal cooling). The core argument is that the risks and benefits are comparable.
- FDA Clearance Letter: Confirming the substantial equivalence determination for the stated indications for use.
- Indications for Use Statement: A formal list of approved uses.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text. This document is a regulatory submission demonstrating equivalence, not a clinical study report with performance data against acceptance criteria.
Based on the provided text, the following information is available or can be inferred:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Devices: | |
| Wavelength: 1064 nm | 1064 nm |
| Pumping mechanism: Flashlamp pumped | Flashlamp pumped |
| Delivery system: Optical fiber and focusing handpiece | Optical fiber delivery system and focusing handpiece |
| Aiming beam classification: Class 1 | Class I aiming beams |
| Control: Microprocessor controlled | Microprocessor controlled devices |
| Thermal control: Internal closed loop water-air heat exchanger | Internal closed loop water-air heat exchanger circuit |
| Clinical Equivalence to Predicate Devices: | |
| Ability to perform indicated surgical and aesthetic applications | Indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue |
| Indicated for stable long-term or permanent hair reduction in Fitzpatrick skin types I-VI. | |
| Risks and benefits comparable to predicate devices | Risks and benefits for the DUALIS family are comparable to the predicate devices when used for similar clinical applications. |
| No new questions of Safety or Effectiveness | Believed that there are no new questions of Safety or Effectiveness raised by the introduction of the DUALIS family. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not describe a clinical study with a test set of data. It is a substantial equivalence submission.
3. 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 / Not provided. No test set or ground truth establishment mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or ground truth establishment mentioned.
5. 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
- No. This is a laser device, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a laser device, not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. The "ground truth" in this context is the performance and safety profile of the predicate devices against which the new device is compared for equivalence. There are no specific "ground truth" measurements for the Fotona DUALIS devices presented in this document.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is not an AI/machine learning device.
§ 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.