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510(k) Data Aggregation
(107 days)
The Intense Pulsed Light System is intended for medical use in the treatment of the following conditions, with treatment filters applied as indicated:
420-1200nm and 515-1200nm: Moderate inflammatory acne vulgaris.
515-1200nm and 560-1200nm: Benign pigmented epidermal lesions (including dyschromia, hyperpigmentation, melasma, and ephelides (freckles)).
515-1200nm and 560-1200nm: Benign cutaneous vascular lesions (including port wine stains, hemangiomas, facial, truncal, and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas, and venous malformations).
590-1200nm, 640-1200nm and 695-1200nm: Permanent hair reduction (long-term stable reduction in the number of hairs regrowing after a treatment regimen).
Intense Pulsed light (IPL) System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm.
There are six optical filters that can be using in this system. With special properties, the IPL System has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption.
Basic parameters/use conditions/power supply specifications is as follows:
| light source | Intense Pulsed Light |
| Filter wavelength nm | 420 | 515 | 560 | 590 | 640 | 695 |
|---|---|---|---|---|---|---|
| Wavelength range(nm) | 420-1200 | 515-1200 | 560-1200 | 590-1200 | 640-1200 | 695-1200 |
| Pulse energy J | 1.9 -87.8 | 1.9-236.2 | 1.9-216 | 1.9-202.5 | 1.9-175.5 | 1.9-148.5 |
| Energy density J/cm² | 5-13 | 5-35 | 5-32 | 5-30 | 5-26 | 5-22 |
| Pulse train width (ms) | 5-500 | 5-200 | ||||
| Pulse train interval time s | 1s-5s |
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