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510(k) Data Aggregation
K Number
K090837Device Name
STRATAPULSE TS AND STRATAPULSE
Manufacturer
ADVANCED MEDICAL PHOTONICS
Date Cleared
2009-06-17
(82 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL PHOTONICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StrataPulse and StrataPulse TS IPL Systems are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions:
- Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen.
- Treatment of:
- Moderate inflammatory acne vulgaris
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles).
- Cutaneous lesions including scars
- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, leg veins and venous malformations.
- Integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during and after light treatment in general aesthetic dermatologic and plastic surgery procedures to:
- Reduce pain during light treatment (via partial anesthesia from cooling).
- Reduce discomfort during and/or associated with light treatment
- Minimize thermal injury, including thermal necrosis, to non-targeted skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hype- and/or hypo pigmentation.
- Allow the use of higher light or laser fluences for light treatments (such as for hair reduction and the treatment of vascular or pigmented lesions)
- Reduce potential side effects of light treatment (such as for hair reduction and the treatment of vascular or pigmented lesions)
Device Description
The StrataPulse IPL system is an intense pulsed light system. This device uses computer controlled power supply, xenon flash-lamp and band-pass filter to generate light pulses of prescribed duration, intensity and spectral distribution. The device is also equipped with cooling systems to maintain both the treatment head and the internal structure of the device at appropriate and safe temperatures. The light pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the device. More specifically, the computer software regulates in a prescribed fashion the outflow of power from the power supply to the flash-lamp such that a flash of intense pulsed light is generated.
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