(139 days)
The Lume 2, with Intense Pulsed Light ( IPL) wavelengths 515-1200 nm, is indicated for the treatment of:
Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos.
Cutaneous lesions, including warts, scars and striae.
Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, and
For the removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
with Nd:YAG laser at wavelength 1064 nm, is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
The removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The non-ablative treatment of facial wrinkles.
1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
The Lume 2 system is a multi-functional platform, computer controlled system which incorporates two technologies and two treatment heads: Intense Pulsed Light (IPL), and Nd:YAG Laser.
The Lume 2 console has a single treatment head connection port that accommodates either the Universal IPL or the Multi-Spot Nd: YAG treatment head.
The treatment heads are attached to the head connector via a flexible cable (umbilical). During operation, deionized water circulates from the system console through the umbilical cable to the treatment heads to cool the flashlamp assembly and/ or the laser head, and the umbilical cable also houses the power cable to provide energy to the light/laser emission and the electrical wiring to power the thermoelectric (TE) cooler. The energy is delivered in pulse sequences, to allow better control.
The principles of operation and fundamental scientific technology are the same for the subject devices and predicate device.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or a detailed performance table. The "Performance Data Summary" section (2) only broadly mentions that "appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Lume 2 system has been conducted."
The primary goal of this 510(k) submission is to demonstrate substantial equivalence to a predicate device (Lumenis One Family of Systems, K060448). This means the device is considered safe and effective if it performs as well as or similarly to the predicate device for its intended uses.
The reported "performance" can be inferred from the stated intended uses, which are the same as the predicate device. These include:
-
Intense Pulsed Light (IPL) (515-1200 nm):
- Treatment of benign epidermal lesions (dyschromia, hyperpigmentation, melasma, freckles, tattoos).
- Treatment of cutaneous lesions (warts, scars, striae).
- Treatment of benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, spider angiomas, poikiloderma of Civatte, leg veins, venous malformations).
- Unwanted hair removal and stable long-term/permanent hair reduction in skin types I-V.
-
Nd:YAG Laser (1064 nm):
- Coagulation and hemostasis of vascular lesions and soft tissue, including treatment and clearance of superficial and deep telangiectasias and reticular veins (0.1-4.0 mm diameter) of the leg.
- Unwanted hair removal and stable long-term/permanent hair reduction in skin types I-V.
- Non-ablative treatment of facial wrinkles.
2. Sample Size and Data Provenance:
The document does not provide any details regarding sample sizes used for testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with specific test sets.
3. Number of Experts and Qualifications:
The document does not mention the use of experts to establish ground truth for a test set. This is consistent with a 510(k) submission based on substantial equivalence, which primarily relies on engineering and safety testing, and comparison to existing data for the predicate device.
4. Adjudication Method:
Given the lack of information on experts and test sets, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that an MRMC comparative effectiveness study was performed. The submission is focused on device safety and performance compared to a predicate, not on human-in-the-loop performance or improvement with AI assistance. The device in question is a laser/IPL system, not an AI-driven diagnostic tool.
6. Standalone Performance Study:
The document does not describe a standalone algorithm-only performance study. As stated, "appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Lume 2 system has been conducted." This likely refers to engineering tests and a comparison of technical specifications and performance characteristics against the predicate device, not a standalone clinical performance study of a diagnostic algorithm.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for any performance evaluation. In the context of demonstrating substantial equivalence for a medical device like this, ground truth would typically be established through:
- Clinical observation and assessment by qualified medical professionals for the predicate device's established efficacy.
- Histopathological confirmation (for certain skin lesions or hair follicle effects, if new clinical data were presented, which they are not in this summary).
- Objective measurements of treatment outcomes (e.g., hair count reduction, lesion disappearance, wrinkle depth reduction).
However, the provided summary focuses on the inherent nature of the device and its operational parameters being similar to the predicate.
8. Sample Size for the Training Set:
The document does not provide any information regarding a training set sample size. This type of device does not typically involve machine learning or AI models that require a "training set" in the conventional sense. The "training" for this device refers to the clinical experience and data accumulated for the predicate device, which informs the understanding of the technology's effectiveness.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of machine learning, there is no information on how ground truth for such a set was established. Instead, the "ground truth" for the device's efficacy is based on the established clinical effectiveness and safety profile of the predicate device, which has a long history of use and documented outcomes.
§ 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.