CeramOptec 503200160

GUDID 04049059519381

The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

CeramOptec GmbH

General/multiple surgical solid-state laser system

• Primary Device ID: 04049059519381
• NIH Device Record Key: 3738d416-96d4-4968-8269-7688890af5de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CeramOptec
• Version Model Number: Leonardo® Duster Fiber 365um Reusable, IC
• Catalog Number: 503200160
• Company DUNS: 325264513
• Company Name: CeramOptec GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049059519381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250504

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-03
• Device Publish Date: 2025-09-25

On-Brand Devices [CeramOptec]

• 04049059301092: Indicated for use in general surgical applications for incision, excision, ablation, cutting, va
• 04049059301009: Indicated for use in general surgical applications for incision, excision, ablation, cutting, va
• 04049059519411: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519404: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519398: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519381: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519374: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519367: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519350: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519343: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519336: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519329: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519312: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519305: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059519299: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo
• 04049059301177: The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemo