SureLase

GUDID 00850013050215

Clinicon "SureLase" 30 Watt Laser System, 3-Year Warranty

Clinicon Corporation

General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system

• Primary Device ID: 00850013050215
• NIH Device Record Key: e4088f4b-2027-4c00-bc4e-ba68fe6f6f7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureLase
• Version Model Number: 4060
• Company DUNS: 785275777
• Company Name: Clinicon Corporation
• 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: true
• 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	00850013050215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121580

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: 2021-05-13
• Device Publish Date: 2021-05-05

Devices Manufactured by Clinicon Corporation

• 00850013050154 - SureGuide: 2021-05-14 SureGuide, 2.00m Fiber Cable Assembly, SMA Connector with Interlock Wire
• 00850013050161 - SureGuide: 2021-05-14 SureGuide, 2.00m Fiber Cable Assembly, ST Connector
• 00850013050178 - SureGuide: 2021-05-14 SureGuide, 2.75m Fiber Cable Assembly,SMA with Interlock Wire
• 00850013050185 - SureGuide: 2021-05-14 SureGuide, 2.75m Fiber Cable Assembly, ST Connector
• 00850013050000 - SureProbe: 2021-05-13 SureProbe, Neuro, 40mm Straight Dissecting Tip Assembly
• 00850013050017 - SureProbe: 2021-05-13 SureProbe, Neuro, 50mm Straight Dissecting Tip Assembly
• 00850013050024 - SureProbe: 2021-05-13 SureProbe, Neuro, 80mm Straight Dissecting Tip Assembly Copy
• 00850013050031 - SureProbe: 2021-05-13 SureProbe, ENT, 50mm, Nasal Straight Dissecting Tip Assembly