ALLY N/A

GUDID 10867744000157

LENSAR, LLC

Femtosecond ophthalmic solid-state laser system

• Primary Device ID: 10867744000157
• NIH Device Record Key: 19f0a229-bd9c-4e1b-880b-a9a24b97482d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALLY
• Version Model Number: 70-00050-001
• Catalog Number: N/A
• 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
• 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
• 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 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between -29 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 101 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867744000150 [Primary]
GS1	10867744000157 [Package]; Contains: 00867744000150; Package: Crate [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220259

FDA Product Code

• OOE: Ophthalmic Femtosecond Laser

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: 2023-08-28
• Device Publish Date: 2023-08-18

Devices Manufactured by LENSAR, LLC

• 10867744000157 - ALLY: 2023-08-28
• 10867744000157 - ALLY: 2023-08-28
• 10867744000102 - LENSAR LLS-fs 3D: 2018-07-06
• 10867744000119 - LENSAR LLS-fs 3D: 2018-07-06