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510(k) Data Aggregation
K Number
K980001Device Name
JENASCAN
Manufacturer
Date Cleared
1998-03-19
(76 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
JENOPTIK LASER, OPTIK, SYSTEME GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The JENASCAN is intended for use as an accessory to surgical lasers, e.g., lasers used in dermatology and plastic surgery, for the ablation and vaporization of soft tissue under conditions of use as described in the manuals accompanying the lasers.
Please refer to the application, operator's, or user's manual(s) accompanying the laser for professional use instructions and detailed use information concerning the laser.
Device Description
The Jenoptik JENASCAN is a microprocessor-controlled accessory for lasers used in dermatology and plastic surgery. The JENASCAN guides the laser energy over the skin during removal of soft tissue under the conditions of labeling as described in the laser operator's manual.
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