(26 days)
The Alma Veil 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 Alma Veil is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce 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 Alma Veil is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The Alma Veil is indicated for temporary and permanent hair reduction. 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 Alma Veil is also indicated for the treatment for pseudofolliculitis barbae.
The Alma Veil is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Alma Veil is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The intended use of the cooling system in the Alma Veil 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 hair 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, hemangiomas (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 Alma Veil is a Nd:YAG laser operating at wavelengths of 1,064 nm and 532 nm. The Alma Veil consists of the main body, optical fiber cable, user-undetachable laser 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 nm.
Let's break down the acceptance criteria and study information for the Alma Veil Laser System based on the provided FDA 510(k) clearance letter.
It's important to note that this document is an FDA 510(k) Clearance Letter and a 510(k) Summary. 510(k) submissions typically rely on demonstrating substantial equivalence to a previously cleared predicate device, rather than requiring extensive de novo clinical trials to prove safety and effectiveness from scratch. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical and, if applicable, clinical data demonstrating that the new device performs as intended and is as safe and effective as the predicate device.
From the provided text, the Alma Veil is a laser system, not an AI/Software as a Medical Device (SaMD) that typically involves complex AI model validation studies with expert ground truth and MRMC studies. The "acceptance criteria" here relate to the device's physical and functional specifications and its safety and performance standards.
Here's the information extracted and organized:
Acceptance Criteria and Device Performance for Alma Veil Laser System
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a laser system and not an AI/imaging device, the "acceptance criteria" are primarily related to meeting recognized performance and safety standards, and demonstrating physical and functional equivalence to the predicate device. The performance is reported by stating compliance with these standards and matching the predicate's parameters.
| Acceptance Criterion | Description / Standard Met | Reported Device Performance (Alma Veil) |
|---|---|---|
| Electrical Safety | Conformance to general requirements for basic safety and essential performance. | Complies with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 |
| Electromagnetic Compatibility (EMC) | Conformance to requirements and tests for electromagnetic compatibility. | Complies with ANSI AAMI IEC 60601-1-2:2014 |
| Usability | Conformance to usability standards. | Complies with IEC 60601-1-6 Edition 3.1 2013 |
| Laser Specific Safety & Performance | Conformance to particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment. | Complies with IEC 60601-2-22 Edition 4 2014 |
| Laser Product Safety Classification | Conformance to equipment classification and requirements for laser product safety. | Complies with IEC 60825-1:2014 (Third Edition) |
| Software Validation | Software designed, developed, verified, and validated according to a software development process, following FDA guidance. | Software validated; classified as MODERATE level of concern. |
| Biocompatibility | Patient-contacting materials evaluated for biocompatibility. | Handpiece Tip (Stainless Steel, Sapphire Window) tested for intact skin contact ( |
§ 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.