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510(k) Data Aggregation
K Number
K111360Device Name
SHEAUMANN PL-980Manufacturer
Date Cleared
2011-09-14
(121 days)
Product Code
Regulation Number
878.4810Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for a medical device (Sheaumann PL-980 laser). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms substantial equivalence to a predicate device based on the indications for use.
Therefore, I cannot provide the requested information from the provided text.
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