(164 days)
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/ Nd: YAG laser systems (and the delivery accessories that are used with them to deliver light and/ or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:
Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm) are indicated for:
- The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars and striae;
- The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melsma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Nd:YAG Laser Wavelength (1064 nm) is indicated for the coagulation and hemostasis of vascular lesions and soft tissue, including:
- Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
- Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
- Reduce discomfort during and/or associated with light or laser treatment;
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper and/or hypopigmentation;
- Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
- Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).
Lumenis Family of Intense Pulsed-Light (IPL) and IPL/ Nd:YAG laser systems are comprised of the following main components:
- A light/laser system console (including software and control electronics);
- A control and display panel;
- One or two attached hand-piece(s), which may have integrated skin cooling components.
The provided document is a 510(k) premarket notification for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies with specific acceptance criteria and performance metrics for a novel device.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:
- No acceptance criteria table or reported device performance: The document does not define specific performance metrics or thresholds for the device's efficacy or safety. It focuses on functional and design equivalence to a predicate device.
- No sample size for test set or data provenance: There is no mention of a test set, its sample size, or the country of origin/retrospective/prospective nature of data.
- No number or qualifications of experts for ground truth: Since there's no defined 'ground truth' or test set evaluation in this type of submission, expert involvement in this context is not applicable or stated.
- No adjudication method: Adjudication methods are not discussed as they relate to validating a test set against a ground truth, which is absent here.
- No multi-reader multi-case (MRMC) comparative effectiveness study: The document does not describe such a study or any effect sizes of human reader improvement with AI assistance, as the device is not an AI-assisted diagnostic tool.
- No standalone (algorithm-only) performance data: The device is a physical laser system, not an algorithm. Standalone performance as an algorithm is not relevant.
- No type of ground truth used: As there's no defined test set for performance evaluation, there's no mention of a ground truth type (e.g., pathology, outcomes data).
- No sample size for the training set: The document doesn't discuss a "training set" in the context of machine learning, as this device is not an AI/ML product.
- No information on how ground truth for the training set was established: This is not applicable for the reasons mentioned above.
The document states the following regarding "Safety and Effectiveness Information":
- "Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective, when indicated in specific applications in the medical specialties of general and plastic surgery, and dermatology."
However, the details of this "clinical data," including acceptance criteria, study design, sample sizes, and specific performance outcomes, are not provided in this summary. The primary basis for clearance is demonstrating "substantial equivalence" to a predicate device (K020839), rather than presenting a de novo study proving novel performance against predefined criteria.
In summary, the provided text describes a 510(k) submission for substantial equivalence of a physical medical device (laser system) and does not contain the detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) typically associated with performance studies for novel or AI/ML-based devices.
§ 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.