Search Results

The SMARTRION COMBI Laser System is indicated for the following:

755nm
The SMARTRION COMBI Laser System is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting for 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 (Fitzpatrick I-VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles. The photo-coagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm
The SMARTRION COMBI Laser System is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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 Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venous lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue.
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 (sigmificant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is indicated for pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.

Not Found

This document is a 510(k) clearance letter for the SMARTRION COMBI / Alexandrite & Long Pulsed Nd:YAG Laser. It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The content provided primarily covers:

• The FDA's determination of substantial equivalence.
• The regulation number and name for the device.
• The regulatory class and product code.
• General controls provisions and other regulatory requirements.
• Indications for Use for both the 755nm and 1064nm wavelengths of the laser system, specifying various treatments like hair reduction, pigmented lesions, vascular lesions, and wrinkles.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text. The document is a regulatory clearance letter, not a clinical study report or a summary of performance data.

Ask a specific question about this device