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510(k) Data Aggregation
K Number
K000222Device Name
UM-L25
Manufacturer
Date Cleared
2000-04-19
(86 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
UNION MEDICAL ENGENEERING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K982860Device Name
UM-L20/ UM-L30
Manufacturer
Date Cleared
1999-08-13
(365 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
UNION MEDICAL ENGENEERING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UM-L20/UML30 CO2 Laser Units are used in the following applications in order to treat the below mentioned conditions: ENT, Plastic & Reconstruction, Dermatology, Podiatry, Dentalogy, General Practice, Gynecology, Proctology. Specific conditions are listed in tables.
Device Description
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