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Found 2 results
510(k) Data Aggregation
K Number
K010316Manufacturer
Date Cleared
2001-05-01
(88 days)
Product Code
Regulation Number
878.4810Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K003781Device Name
COOLTOUCH VARIA-II ND:YAG LASER SYSTEMManufacturer
Date Cleared
2000-12-20
(13 days)
Product Code
Regulation Number
878.4810Type
SpecialReference & Predicate Devices
N/A
Why did this record match?
Device Name :
COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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