(59 days)
The Light Age EpiCare™ Alexandrite Laser is intended for use in dermatology for the removal of dark, unwanted body hair.
The Light Age EpiCare™ Alexandrite Laser is a medical device capable of emitting an invisible pulsed treatment laser beam with a wavelength of 755 mm under the guidance of a visible aiming beam. This laser can be utilized in either a continuous or timed-exposure mode of operation.
The provided text describes a 510(k) summary for the Light Age EpiCare™ Alexandrite Laser, claiming substantial equivalence to a predicate device, the Sharplan Model 5000 Alexandrite Laser System.
Based on the provided text, the following information regarding acceptance criteria and studies is available:
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Substantial equivalence to predicate device (Sharplan Model 5000 Alexandrite Laser System) in design and clinical perspective. The Light Age EpiCare™ Alexandrite Laser is stated to be of "identical design" and have the "same intended use" as the predicate device. Light Age, Inc. previously supplied internal components for the Sharplan Model 5000 and is now taking over final assembly, sales, and distribution without product changes or new indications. Intended use: removal of dark, unwanted body hair. The device is intended "for use in dermatology for the removal of dark, unwanted body hair." Safety and effectiveness. "The safety and effectiveness of the Light Age EpiCare™ Alexandrite Laser is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device..." The document asserts that "As the predicate and candidate devices are identical in design and overall performance characteristics, the Light Age EpiCare™ Alexandrite Laser should not raise any concerns regarding its overall safety or effectiveness." Wavelength: 755 mm. The device emits an "invisible pulsed treatment laser beam with a wavelength of 755 mm." Operation mode: continuous or timed-exposure. The device "can be utilized in either a continuous or timed-exposure mode of operation." -
Sample size used for the test set and the data provenance:
The document does not describe a specific test set or clinical study conducted for the Light Age EpiCare™ Alexandrite Laser itself. Instead, it relies on the safety and effectiveness data of the predicate device, the Sharplan Model 5000 Alexandrite Laser System, which FDA reviewed under K973354 and K971874. A letter of authorization from ESC Medical Systems was provided to allow FDA access to this predicate data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no new clinical study data for the Light Age EpiCare™ Alexandrite Laser is presented or described in this 510(k) summary. The determination is based on the previously established ground truth for the predicate device, which is not detailed here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no new clinical study data for the Light Age EpiCare™ Alexandrite Laser is presented or described in this 510(k) summary.
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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 device is a medical laser for hair removal, not an AI-assisted diagnostic or imaging tool involving human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a medical laser, not an algorithm. Performance is assessed based on its physical characteristics and equivalence to the predicate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the Light Age EpiCare™ Alexandrite Laser, the "ground truth" for its safety and effectiveness is established by its substantial equivalence to the predicate device, the Sharplan Model 5000 Alexandrite Laser System, along with the safety and effectiveness data previously submitted for that predicate device (K973354, K971874). The specific types of ground truth (e.g., patient outcomes, clinical measurements) used in the predicate device's evaluation are not detailed in this summary.
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The sample size for the training set:
Not applicable. The device is a physical medical laser, not a machine learning model requiring a training set.
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How the ground truth for the training set was established:
Not applicable, for the same reason as point 8.
§ 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.