(86 days)
The Intense Pulsed Light System is intended for medical use in the following conditions:
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Moderate inflammatory acne vulgaris;
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Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
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Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations;
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Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.
Intense Pulsed light (IPL) System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. There are six optical filters that can be using in this system listed in table. With these special properties, the IPL System has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption.
The provided document is a 510(k) premarket notification for an Intense Pulsed Light System. It details the device's indications for use, technological characteristics, and comparison to a predicate device. However, the document does not contain information on acceptance criteria for a study demonstrating device performance against specific metrics, nor does it describe a study involving human subjects or AI performance.
The "Performance Data" section of the document primarily addresses:
- Electrical safety and electromagnetic compatibility: Compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 62471, and IEC 60601-2-57.
- Software Verification and Validation Testing: Stating that V&V testing was conducted, and the software was considered "moderate" level of concern.
- Sterilization and Shelf-Life: Asserting the device is not sterile, is reusable, and has no restricted shelf-life.
- Biocompatibility: Reporting results of cytotoxicity, sensitization, and irritation tests on the handpiece sapphire tip, concluding compliance with ISO 10993-1.
- Bench testing: Verifying that the spatial variation of the light source equipment output over the treatment area does not deviate by more than ±20%, and fulfilling IEC 60601-2-57 requirements.
Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance (in the context of clinical or AI performance), sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC study details, standalone AI performance, type of ground truth, training set sample size, or how training ground truth was established.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and compliance with safety and bench testing standards, rather than proving efficacy or performance through clinical endpoint studies or AI-driven assessments.
§ 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.