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510(k) Data Aggregation
K Number
K111360Device Name
SHEAUMANN PL-980
Manufacturer
Date Cleared
2011-09-14
(121 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHEAUMANN LASERS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PL-980 laser and collimated handpiece will be indicated for ablation, vaporizing, excision, incision, and coagulation of soft tissue encountered in dermatology and plastic surgery, including but not limited to vascular lesions such as telangiectasia and angiomas.
Device Description
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K Number
K111359Device Name
SHEAUMANN PL-1064
Manufacturer
Date Cleared
2011-09-13
(120 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHEAUMANN LASERS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PL-1064 laser, collimated handpiece will be indicated for ablation, vaporizing, excision, incision, and coagulation of soft tissue encountered in dermatology, plastic surgery, and podiatry including but not limited to plantar warts, periungual and subungual warts and telangiectasia.
Device Description
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