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510(k) Data Aggregation
K Number
K040103Device Name
SOUNDSKIN PHOTOTHERAPY SYSTEM
Manufacturer
BHC INTERNATIONAL, LTD.
Date Cleared
2005-01-18
(364 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BHC INTERNATIONAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Soundskin Phototherapy System is generally indicated to treat dermatological conditions, specifically indicated to treat moderate inflammatory Acne Vulgaris.
Device Description
The Soundskin Phototherapy System is a visible light source of high spectral purity, it provides uniform illumination of red light and blue light within the same lamp housing. The output is pre-tuned to one wavelength for each light, with a narrow spectral handwidth of 635 +/-5nm for red light and an output of 435 +/- 5nm bandwidth for blue light. The light output is 2460 mW ner sa cm of the treatment area with a lamp efficiency of 95% of the nutput. This compares with laser outputs which are approximately 2300-2500 mW per sq cm of area covered when measured in joules the output can average between 15 and 600 per sq cm. We have supplied technical data sheets and charts for the information requested.
The Soundskin system is in three parts, the hase unit contains the power supply and electronic control unit, the programme is electronic timed through mechanical relays instead of software for simplicity und reliability. The red light runs for 10 minutes then changes to blue light for 10 minutes, at the end of the 20 minute cycle it automatically shuts off. There is a separate mains supply switch attached to the base unit and a single on off switch on the lamp housing everything is uutomatic operation. A three part arm attached to the base unit supports the lamp housing, the head is attached to the end of the arm with a multifunctional positioning for natient treatment. The automatic controlled electronics operate from a single reset button on the lamp housing for easy access.
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