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510(k) Data Aggregation
K Number
K093627Device Name
IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650
Manufacturer
SHANGHAI APOLO MEDICAL TECHNOLOGIES CO., LTD.
Date Cleared
2011-01-18
(421 days)
Product Code
ONF, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI APOLO MEDICAL TECHNOLOGIES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
iPulseLight IPL System (HS 300C, HS 650) 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,
spider anglomas and venous malformations.
The integrated thermal cooling is indicated for use in cooling the treatment site prior to, during, and after light treatment in general aesthetic dermatologic and plastic surgery procedures.
- 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-target skin and skin i s tructures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypo pigmentation
Allow the use of higher light or laser fluencies for light treatments (such as for hair removal and the treatment of . vascular or pigmented lesions)
Reduce potential side effects of light treatments (such as for hair removal and the treatment of vascular or pigmented i lesions)
Device Description
iPulseLight IPL System is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. With these special properties, the IPL has a wide application in non-ablative therapies based on theory of human skin tissue's selective absorption and photothermolysis of light sources. Meanwhile, IPL treatment is more effective, with no downtime and can make the patients get recovered more quickly than conventional therapies.
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