(42 days)
The Cynosure Apogee Elite laser is indicated for permanent hair reduction and the treatment of vascular lesions, pigmented lesions, and wrinkles.
755 nm:
The Cynosure Apogee Elite Dermatological Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. It is used for all skin types (Fitzpatrick I - VI) including tanned skin.
It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm:
The Cynosure Apogee Elite Dermatological laser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is 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.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).
Cynosure Apogee Elite laser (755nm), having an Alexandrite crystal rod as the lasing medium, with a wavelength of 755 nm. The 1064 nm wavelength is generated from the Nd:YAG laser head. Laser activation is by either finger or foot switch. Overall weight of the laser is 45 Kg, and the size is 113x53x84 cm (HxWxD). Electrical requirement is 230 VAC, 50A, 50-60 Hz, single phase.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Cynosure Apogee Elite Laser:
This 510(k) summary does not include any acceptance criteria or a study proving the device meets said criteria. Instead, it relies on substantial equivalence to predicate devices.
Let's break down the reasons and why this document doesn't fit the request:
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A table of acceptance criteria and the reported device performance:
- Not found. This document explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none."
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Sample size used for the test set and the data provenance:
- Not found. Since no studies were conducted or provided, there is no test set or data provenance to report.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not found. No test set means no ground truth establishment by experts.
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Adjudication method for the test set:
- Not found. No test set means no adjudication method.
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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. This device is a laser system, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical laser system, not a software algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- Not found. No ground truth was established as no performance data was provided for the device.
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The sample size for the training set:
- Not found. No training set was used as no new performance data was generated for this 510(k). The device is cleared based on equivalence.
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How the ground truth for the training set was established:
- Not found. No training set means no establishment of ground truth for it.
Summary of the document's approach:
The Cynosure Apogee Elite Laser's 510(k) submission relies on demonstrating substantial equivalence to already legally marketed devices (Cynosure Apogee TKS, Cynosure Acclaim). This means the manufacturer argues that their new device is as safe and effective as existing predicate devices because it shares the "same principle of operation, the same wavelength and essentially the same power range and the same indications for uses."
Therefore, this document does not contain the information requested about specific acceptance criteria or performance studies demonstrating the device meets those criteria. It is a clearance based on comparison rather than new performance data.
§ 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.