PASCAL Laser Indirect Ophthalmoscope SA-06201

GUDID 00855005006140

KIT, PASCAL LIO, GREEN, PASCAL B RELEASE

TOPCON MEDICAL LASER SYSTEMS, INC.

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• Primary Device ID: 00855005006140
• NIH Device Record Key: 2088ec58-22a6-4fe1-949a-e0b96a24ce6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PASCAL Laser Indirect Ophthalmoscope
• Version Model Number: LIO for PASCAL Photocoagulator 532
• Catalog Number: SA-06201
• Company DUNS: 041376321
• Company Name: TOPCON MEDICAL LASER SYSTEMS, INC.
• 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

Customer Support Contacts

• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com
• Phone: +1(888)850-1223
• Email: tmlsservice@topcon.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855005006140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123056

FDA Product Code

• HQF: Laser, ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-18
• Device Publish Date: 2016-04-15

On-Brand Devices [PASCAL Laser Indirect Ophthalmoscope]

• 00855005006140: KIT, PASCAL LIO, GREEN, PASCAL B RELEASE
• 00855005006133: KIT, PASCAL LIO, 577nm, PASCAL SYNTHESIS D RELEASE
• 00855005006126: KIT, PASCAL LIO, 532 nm PASCAL SYNTHESIS D RELEASE
• 00855005006119: KIT, PASCAL LIO, YELLOW, PASCAL STREAMLINE B RELEASE (577)
• 00855005006102: KIT, PASCAL LIO, GREEN, PASCAL STREAMLINE B RELEASE (532)