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510(k) Data Aggregation
K Number
K053324Device Name
CHROMOLITE SYSTEM
Manufacturer
CHROMOGENEX PLC
Date Cleared
2006-01-05
(35 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CHROMOGENEX PLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chromolite™ System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:
- 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 lesions, . including port wine stains, hemangiomas, facial, truncal and leq 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.
Device Description
The Chromolite™ is a Intense Pulsed Light-based medical device utilising xenon flashlamp technology to illuminate the dermis to offer light based therapies as listed in the indications of use. The Chromolite™ emits light at 390nm to 1200nm via a 50mm x 15mm waveguide at a repetition rate of 0.5Hz.
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