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MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600U — Biolitec, Inc. (510(k) K010689)

MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600U — Biolitec, Inc. (510(k) K010689) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600U; Applicant: Bio

Device nameMEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600U
ApplicantBiolitec, Inc.
Clearance track510(k)
Submission numberK010689
DecisionSubstantially Equivalent
Decision date2001-05-18
Date received2001-03-08
Product codeGEX
Device class2
Medical specialtyGeneral, Plastic Surgery
Applicant locationMA, US
SourceopenFDA device

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