(64 days)
The CuRAS Nd; Y AG laser system in indicated for : the incision, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength :
- Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
- Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
- Tattoo removal: dark ink (black, blue and brown)
- Removal of Nevus of Ota
- Removal or lightening of unwanted hair with or without adjuvant preparation.
- Treatment of Common Nevi
- Skin resurfacing procedures for the treatment of acne scars and wrinkle
The CuRAS Nd;YAG laser system is comprised of the following major components:
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- The main console unit
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- Delivery handpieces
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- Footswitch.
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- Accessories
The provided text is related to a 510(k) premarket notification for a medical device (CuRAS Nd:YAG Laser) and primarily focuses on its substantial equivalence to a predicate device. It details product specifications, intended use, and technical comparisons.
However, the document does not contain information regarding acceptance criteria, specific device performance metrics in the context of a study, sample sizes for test/training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a training set.
The document explicitly states under "VIII. Clinical Data [21 CFR 807.92(b) (2)]":
"Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission."
Therefore, I cannot provide the requested information as it is not present in the given text. The document refers to compliance with safety standards (IEC 60601-series and IEC 60825-1) and software verification/validation, but these are general compliance requirements rather than specific performance studies with acceptance criteria as typically understood in the context of diagnostic or AI-driven device performance.
§ 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.