(171 days)
WON Technology's Pastelle Q-Switched Nd:YAG Laser System is indicated for the Incision, Excision, Ablation and Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
The WON Technology's Pastelle Q-Switched Nd:YAG Laser uses a Nd: YAG material to generate the Qswitching laser. The device is comprised of a main body, articulated arm, foot switch and ancillary accessories. This device is designed to provide laser energy for use in a variety of dermatological procedures. The 532nm and 1064nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect. The laser incorporates very broad laser pulses (6-20ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.
The WON Technology Pastelle Q-Switched Nd:YAG Laser (K123293) did not conduct a clinical study. Instead, its performance was evaluated through a comparison of its technological characteristics with a legally marketed predicate device, the Continuum-Electro Optics, Inc. MedLite C6 Q-Switched Nd:YAG Laser (K014234). The device also underwent bench testing, which included software validation, electrical safety, electromagnetic compatibility, transit testing, and functional testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate: MedLite C6 K014234) | Reported Device Performance (Pastelle K123293) |
|---|---|---|
| Laser Type | Q-Switched Nd:YAG | Q-Switched Nd:YAG |
| Wavelength | 532nm, 1064nm | 532nm, 1064nm |
| Pulse | Single, 1, 2, 5 and 10Hz | Single, 0-10Hz ±20% |
| Pulse duration | 5 to 20ns | 6 to 20ns |
| Power Requirement | 220V AC, 50/60Hz; 110V AC, 50/60Hz | 220V-230V AC, 50/60Hz |
| Spot size | 3, 4, 6, 8mm at 1064nm; 2, 3, 4, 6mm at 532nm | 2mm to 10mm; Control value: 1mm |
| Energy per pulse (MAX) | 1000mJ at 1064nm; 400mJ at 532nm | 1300mJ at 1064nm; 500mJ at 532nm |
2. Sample size used for the test set and the data provenance:
No clinical test set was used for this device. The evaluation was based on a comparison of technological specifications and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set was used.
4. Adjudication method for the test set:
Not applicable, as no clinical test set was used.
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:
Not applicable, as no MRMC study or AI component was involved.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this is a laser device, not an algorithm.
7. The type of ground truth used:
For the comparison of technological characteristics, the ground truth was the published specifications of the legally marketed predicate device (Continuum Electro-Optics, Inc. MedLite C6 Q-Switched Nd:YAG Laser, K014234). For the bench studies, the ground truth was the expected functional performance and compliance with relevant safety and electromagnetic compatibility standards.
8. The sample size for the training set:
Not applicable, as this device does not involve a training set as it's not an AI/ML-based device.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.