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Ceram Optec, Inc.

US

Last updated May 24, 2026

Part of CeramOptec GmbH

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
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Catalogue (33)

DeviceModel / ReferenceRegistriesClassStatus
CeramOptec Leonardo® DUAL 45
FDA UDI
Class IIActive
CeramOptec Leonardo® Mini Blue
FDA UDI
Class IIActive
CeramOptec Leonardo® DUAL 200
FDA UDI
Class IIActive
Ceralas D10 810nm Laser, Model Ceralas D10-60 K001975
FDA 510(k)
Class IIActive
Megabeam Endo-Ent Probe K952772
FDA 510(k)
Class IIActive
Mis K923543
FDA 510(k)
Class IIActive
Ceralas D 980nm Diode Laser System, Model D15 K993002
FDA 510(k)
Class IIActive
Ceralas G Nd;yag Laser System (ceralas G) K962948
FDA 510(k)
Class IIActive
Ceralas Diode Laser System (model Ceralas D50) K951775
FDA 510(k)
Class IIActive
Ceralas Diode Laser System (ceralas D15) K964497
FDA 510(k)
Class IIActive
Ceralas G15 532nm Frequency Doubled Nd:yag Laser, Model G1-G15 K002296
FDA 510(k)
Class IIActive
Megabeam Fiber Optic Delivery System K943445
FDA 510(k)
Class IIActive
Ceralas Diode Laser System, Model Ceralas D15 K991891
FDA 510(k)
Class IIActive
Ceralas G Frequency Doubled Nd;yag Laser System K954834
FDA 510(k)
Class IIActive
Ceralas G Frequency Doubled Nd: Yag Laser Systems, Ceralas G3 K981126
FDA 510(k)
Class IIActive
Reusable Megabeam Fiber Optic Delivery System K980838
FDA 510(k)
Class IIActive
Megabeam Dental Fiber K942182
FDA 510(k)
Class IIActive
Megabeam Reusable Fiber Optic Handpiece And Needles K980389
FDA 510(k)
Class IIActive
Ceralas F Nd:yag Laser System K953851
FDA 510(k)
Class IIActive
Ceralas Diode Laser System (model H) K983950
FDA 510(k)
Class IIActive
Megabeam Aspirating Endocular Probe K952340
FDA 510(k)
Class IIActive
Ceralas D10 810nm Diode Laser K992773
FDA 510(k)
Class IIActive
Megabeam Lateral Fire K943444
FDA 510(k)
Class IIActive
Megabeam Lateral Fire K943527
FDA 510(k)
Class IIActive
Ceralas Diode Laser System (ceralas D2) K964751
FDA 510(k)
Class IIActive
Megabeam Lateral Fire Fiber Optic Delivery System K943526
FDA 510(k)
Class IIActive
Ceralas D Laser System, Model # Ceralas D15 K983058
FDA 510(k)
Class IIActive
Ceralas D10 810nm Diode Laser K993828
FDA 510(k)
Class IIActive
Megabeam K923953
FDA 510(k)
Class IIActive
Ceralas D Diode Laser System, Model D15, D25, D50 K993911
FDA 510(k)
Class IIActive
Megabeam Radial Emit Shape Fiber Optic Deliv Syst K924258
FDA 510(k)
Class IIActive
Megabeam Endocular Probe K935747
FDA 510(k)
Class IIActive
Megabeam Lateral Fire Fiber Optic Delivery Syst K934008
FDA 510(k)
Class IIActive

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