LENSAR LLS-fs 3D

GUDID 10867744000119

LENSAR, LLC

Femtosecond ophthalmic solid-state laser system

• Primary Device ID: 10867744000119
• NIH Device Record Key: 27ec264d-65fe-496c-a06a-7fb6544b9449
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LENSAR LLS-fs 3D
• Version Model Number: 70-00013-001
• Company DUNS: 080387995
• Company Name: LENSAR, LLC
• 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: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com
• Phone: 888-536-7271
• Email: service@lensar.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -29 Degrees Celsius and 59 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867744000112 [Primary]
GS1	10867744000119 [Package]; Contains: 00867744000112; Package: Crate [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143010

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [LENSAR LLS-fs 3D]

• 10867744000119: 70-00013-001
• 10867744000102: 70-00005-001