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510(k) Data Aggregation
K Number
K111501Device Name
I-LIPO SYSTEM
Manufacturer
CHROMOGENEX TECHNOLOGIES LIMITED
Date Cleared
2012-03-23
(297 days)
Product Code
OLI
Regulation Number
878.5400Why did this record match?
Applicant Name (Manufacturer) :
CHROMOGENEX TECHNOLOGIES LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The i-lipo™ Low Level Laser System is indicated for Non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.
Device Description
The i-lipo™ System consists of a main unit, and applied parts consisting of various laser diode cluster probes and pads. The Main Unit contains the mains input, fuses, power supply, relay, control circuits, LCD display, membrane function buttons, emergency stop, and key switch. The cluster probes and pads, which are placed against the patients skin, contain the Laser diodes. Laser energy promotes disruption of adipocyte cells within the fat layer for release of fat and lipids from these cells for non-invasive aesthetic use.
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K Number
K081619Device Name
CHROMOLITE EP
Manufacturer
CHROMOGENEX TECHNOLOGIES LIMITED
Date Cleared
2008-07-18
(39 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CHROMOGENEX TECHNOLOGIES LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use for Fitzpatrick skin types (I to V).
The Chromolite™ EP System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostatis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:-
Indications for use for Fitzpatrick skin types (I to V).
- . The treatment of moderate inflammatory acne vulgaris
- The treatment of benign pigmented epidermal lesions including dyschromia, hyper-. pigmentation, melasma, ephelides (freckles)
- . The treatment of cutaneous lesions including warts,scars, and striae.
- . The treatment of benign cutaneous vascular lesioins, including port wine stains, hemamangiomas, facial, truncal, and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
- . The removal of unwanted hair and to effect stable long-term or permanent hair reduction.
1 = Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
Device Description
The Chromolite™ EP System is an Intense Pulsed Light-based medical device utilising xenon flashlamp technology to illuminate, to offer light based therapies as listed in the indications for use. The Chromolite" " EP System emits light at 390nm to 1200nm via a 50mm x 15mm waveguide at a repetition rate of up to 0.5Hz.
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