Opelaser

GUDID 04547497771052

YOSHIDA DENTAL MFG. CO., LTD., THE

Dermatological carbon dioxide laser system

• Primary Device ID: 04547497771052
• NIH Device Record Key: c4472e37-b1c0-4f28-bac0-eae3ddd9bce4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opelaser
• Version Model Number: Opelaser PROⅡ
• Company DUNS: 690676978
• Company Name: YOSHIDA DENTAL MFG. CO., LTD., THE
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547497771052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120932

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[04547497771052]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-01-26

On-Brand Devices [Opelaser ]

• 04547497771090: Opelaser Lite Ⅱ
• 04547497771052: Opelaser PROⅡ