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510(k) Data Aggregation
K Number
K230268Device Name
ZenPro 40
Manufacturer
Date Cleared
2023-08-10
(191 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Bluecore Company Co Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. Fractional mode is indicated for only ablative skin resurfacing
Device Description
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