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510(k) Data Aggregation
(183 days)
The CoolTouch PRIMA Pulsed Light Therapy System is indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, tattoos, pigmented lesions, lentigenes, and mild to moderate inflammatory acne vulgaris.
The CoolTouch PRIMA Pulsed Light Therapy System is a compact, self-contained system that delivers a beam of pulsed light at wavelengths of 300nm to 1400nm, which can be optimized at various wavelength ranges and delivered to the treatment site. The system consists of a control console unit. which houses the power supply, cooling system, cryogen source, and microcontroller, the handpiece, which contains the light source, and the footswitch.
The provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria.
Instead, it's a 510(k) summary for the CoolTouch PRIMA Pulsed Light Therapy System, focusing on its substantial equivalence to predicate devices for various dermatological treatments. The document explicitly states "Nonclinical Performance Data: None. Clinical Performance Data: None."
Therefore, I cannot provide the requested information based on the given text.
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(179 days)
The New Star Lasers UV-300 Pulsed Light Therapy System is indicated for the treatment of facial, truncal or leg telangiectasia and/or reticular veins, rosasia, port wine stains, hemangiomas, psoriasis, vitiligo, vascular lesions, atopic dermatitis (eczema), seborrheic dermatitis, hair removal, and tattoos. The UV-300 may be used to treat patients with skin types I-VI.
The New Star UV-300 Pulsed Light Therapy System is a compact, self-contained system that delivers a beam of pulsed light at wavelengths of 300nm to 1400nm, which can be optimized at various wavelength ranges and delivered to the treatment site. The system consists of a control console unit, which houses the power supply, cooling system, cryogen source, and microcontroller, the handpiece, which contains the light source, and the footswitch.
The provided document (K024259) is a 510(k) premarket notification for the New Star Lasers UV-300 Pulsed Light Therapy System. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical performance studies to prove specific acceptance criteria.
Therefore, the document explicitly states:
- Nonclinical Performance Data: None.
- Clinical Performance Data: None.
Given this, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such studies were not part of this 510(k) submission.
The "conclusion" in the 510(k) summary is that the device is "substantially equivalent to other existing pulsed light systems in commercial distribution for treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, and tattoos." This substantial equivalence is based on the device's design, intended use, and technological characteristics being similar to the identified predicate devices, not on new performance data against specific acceptance criteria.
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