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510(k) Data Aggregation
K Number
K001784Device Name
VIRIDIS LASER
Manufacturer
COSMOS MEDICAL TECHNOLOGY
Date Cleared
2000-09-11
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
COSMOS MEDICAL TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001704Device Name
ATHOS
Manufacturer
COSMOS MEDICAL TECHNOLOGY
Date Cleared
2000-08-31
(87 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
COSMOS MEDICAL TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983020Device Name
COMPACT KTP LASER
Manufacturer
COSMOS MEDICAL TECHNOLOGY
Date Cleared
1998-11-25
(86 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
COSMOS MEDICAL TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The COMPACT-KTP-laser-is-intended-for-the-coagulation, ablation- vaporization, incision, excision, and/or cutting of soft tissue in dermatology.
Examples of applications include:
- Benign Vascular Lesions Port Wine Stains Erythrosis Couperosis Facial Telangiectasias Leg Veins - Micro-varicosities Benign Pigmented Lesions Senile Lentigo
- The examples are not intended to be exhaustive or complete but-to serve as a general guide to surgeons.
Device Description
The COSMOS Medical Technology COMPACT KTP laser emits a beam of coherent light at 532 nanometers as do the predicate devices.
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