(123 days)
The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm:
Dermatology:
The V-Laser is intended for the coagulation ans hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, and poikloderma of civate; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scriae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.
Additionally, the lasers are indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The V-Laser is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The V-Laser is indicated for temporary and permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The V-Laser is also indicated for the treatment for pseudofolliculitis barbae.
The V-Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vasularity is an integral part of the scar.
The V-Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The intended use of the cooling system in the V-Laser handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as harr removal and vascular lesions; and to reduce the potential side effects of laser treatments.
532 nm:
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
The V-Laser is a Nd: YAG laser operating at wavelengths of 1,064 nm and 532 mm. The V-Laser consists of the main body, optical fiber cable, user handpiece, handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered through the optical fiber terminated by the handpiece. The fluence (energy density), frequency and pulse are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
For treatment, the user can select the appropriate fluence value. The energy is changed automatically in accordance with the selected fluence value and selected spot size. The user can change the fluence value by pressing (+ (up) and/or == (down) button.
The selectable fluence values are 2 to 300 J/cm2 at 1064 nm and 1.8 to 42 J/cm2 at 532 mm.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria beyond general safety and equivalence to predicate devices. The information primarily focuses on the device's indications for use, technical specifications, and non-clinical testing for regulatory conformance.
Here's an analysis of what is and isn't available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a specific table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) or clinical outcomes. Instead, it lists conformance to various international standards for medical electrical equipment, including safety, electromagnetic compatibility, usability, and particular requirements for laser equipment.
| Standard (Edition) | Standard Title | Conformance (Implied) |
|---|---|---|
| AASI AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance | Met |
| ANSI AAMI IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Met |
| IEC 60601-1-6 Edition 3.1 2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Met |
| IEC 60601-2-22 Edition 4 2014 | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | Met |
| IEC 60825-1:2014 (Third Edition) | Safety of laser products - Part 1: Equipment classification and requirements | Met |
The document also provides technical specifications for the V-Laser, which are compared to predicate devices for substantial equivalence. These are not "acceptance criteria" in the sense of a performance study, but rather characteristics for comparison.
| Characteristic | V-Laser Performance (Proposed Device) |
|---|---|
| Wavelength | 1064 nm, 532 nm |
| Spot Size | 1064 nm: 2 to 12 mm; 532 nm: 2 to 12 mm; Genesis: 8mm |
| Fluence | 1064 nm: 2 to 300 J/cm²; 532 nm: 1.8 to 42 J/cm²; Genesis Mode: 4 to 7 J/cm² |
| Pulse Duration | 1064 nm: Max. 60 ms; 532 nm: Max. 40 ms; Genesis Mode: Max. 0.3 ms |
| Repetition Rate | Max. 10 Hz |
| Laser Media | Flashlamp-pumped solid-state rod |
| Aiming Beam | 635 nm |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "No clinical studies were considered to be necessary for this pre-market notification." Therefore, there is no test set in the sense of patient data for clinical performance evaluation. The testing performed was non-clinical, focusing on compliance with safety and performance standards for laser devices.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable, as no clinical studies with patient data requiring expert ground truth were conducted or presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies with patient data were conducted or presented.
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. The V-Laser is a laser surgical instrument, not an AI-assisted diagnostic or interpretive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical laser system, not an algorithm, and is intended for use by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the relevant international standards (e.g., IEC, ANSI AAMI).
8. The sample size for the training set:
Not applicable, as no machine learning algorithm or AI component is described as being trained.
9. How the ground truth for the training set was established:
Not applicable, as no machine learning algorithm or AI component is described.
In summary:
The provided 510(k) summary focuses on demonstrating substantial equivalence to previously cleared predicate devices (K221427 and K153671) through a comparison of technological characteristics and adherence to recognized performance and safety standards for laser surgical instruments. It explicitly states that no clinical studies were deemed necessary for this pre-market notification, which means there is no data presented in this document regarding clinical acceptance criteria, patient test sets, expert ground truth, or performance metrics like sensitivity/specificity.
§ 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.