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

Clearance record K132475

FLUOBEAM 800 CLINIC LASER IMAGING DEVICE AND FLUOCASE 800 CONTROL SYSTEM · Fluoptics · decided 2014-05-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
PHOTONVUE OPTICAL HEADPVUECOH-1.0FLUOPTICSOWNB475PVUECOH100
FLUOBEAM SYSTEM STORED INTO FLUOBOXFX-CL v1.1FLUOPTICSOWNB475FXCLV111
FLUOBEAM 800FB800-CL v1.9FLUOPTICSOWNB475FB800CLV190
PHOTONVUEPVUEC0A2 V1.0FLUOPTICSOWNB475PVUEC0A2V100
Photonvue boxPVUE-TSC-1.0FLUOPTICSOWNB475PVUETSC101
FLUOBEAM 800FB800-CL v1.8FLUOPTICSOWNB475FB800CLV180
FLUOCASE 800FC800-CL v1.9FLUOPTICSOWNB475FC800CLV190
PHOTONVUE CONTROL BOXPVUECCB-1.0FLUOPTICSOWNB475PVUECCB100
FLUOCASE 800FC800-CL v1.8FLUOPTICSOWNB475FC800CLV180
PHOTONVUEPVUEC0A1 V1.0FLUOPTICSOWNB475PVUEC0A1V100