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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K134010

CABOCHON SYSTEM · Cabochon Aesthetics, Inc. · decided 2014-04-14 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Cellfina Motor Module Device and PackageCM1 Rev BUlthera, Inc.OUP00840763100117
Cellfina Prep PackCP1 Rev CUlthera, Inc.OUP00840763100124
Cellfina System Disposable TrayCK1 Rev. FUlthera, Inc.OUP00840763100094