CeramOptec

GUDID 04049059301009

Indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.

CeramOptec GmbH

General/multiple surgical solid-state laser system

• Primary Device ID: 04049059301009
• NIH Device Record Key: 3705e36e-ac04-4b1e-882f-23a55a254e78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CeramOptec
• Version Model Number: Leonardo® DUAL 45
• 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	04049059301009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120231

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: 2024-11-25
• Device Publish Date: 2024-11-15

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