(54 days)
The Nd:YAG 1064 Laser is intended for:
• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of Pseudofolliculitis Barbae (PFB). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The lasers are indicated on all skin types, such as Fitzpatrick I-VI, including tanned skin.
· Photocoagulation and hemostasis of benign pigmented and vascular lesions such as but not limited to port-wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
· Coagulation and hemostasis of soft tissue.
· Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sunspots cafe au lait macules, sebortheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis), tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lessons to reduce lesion size, for patients with benign that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments.
· Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
· Treatment of wrinkles.
· Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.).
The Alexandrite 755 laser is intended for:
· Temporary hair reduction.
· Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types, such as Fitzpatrick I - V1, including tanned skin.
· Treatment of benign pigmented lesions.
· Treatment of wrinkles.
· Photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas).
The Alex+Nd:YAG (755 + 1064 lasers) is intended for:
· Stable long-term or permanent hair reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
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The provided text is a 510(k) clearance letter from the FDA for a laser device (Splendor X). It confirms the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device submission.
The document is purely a regulatory clearance notice for a physical laser device and does not discuss AI/ML performance or validation studies. Therefore, I cannot extract the requested information from this text.
§ 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.