FEMTO 510.003.009

GUDID 07640167750573

SIE AG, Surgical Instrument Engineering

Femtosecond ophthalmic solid-state laser system

• Primary Device ID: 07640167750573
• NIH Device Record Key: 89e0e5ff-760a-4d46-9aa0-5e4208098f9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FEMTO
• Version Model Number: Z8 NEO
• Catalog Number: 510.003.009
• Company DUNS: 482163628
• Company Name: SIE AG, Surgical Instrument Engineering
• 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: 8667084490
• Email: usa@ziemergroup.com
• Phone: 8667084490
• Email: usa@ziemergroup.com
• Phone: 8667084490
• Email: usa@ziemergroup.com
• Phone: 8667084490
• Email: usa@ziemergroup.com
• Phone: 8667084490
• Email: usa@ziemergroup.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 860 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640167750573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213559

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: 2022-06-21
• Device Publish Date: 2022-06-10

Devices Manufactured by SIE AG, Surgical Instrument Engineering

• 07640167750573 - FEMTO: 2022-06-21
• 07640167750573 - FEMTO: 2022-06-21
• 07640167751334 - Procedure Pack Z8: 2020-12-30 Procedure Pack for Cataract Surgery SLIM
• 07640167751341 - Procedure Pack Z8: 2020-12-30 Procedure Pack Corneal Surgery 8.5 SLIM
• 07640167751358 - Procedure Pack Z8: 2020-12-30 Procedure Pack Corneal Surgery 9.0 SLIM
• 07640167751365 - Procedure Pack Z8: 2020-12-30 Procedure Pack Corneal Surgery 9.5 SLIM
• 07640167751372 - Procedure Pack Z8: 2020-12-30 Procedure Pack Corneal Surgery 10.0 SLIM
• 07640167751389 - Procedure Pack Z8: 2020-12-30 Procedure Pack Corneal Surgery Liquid SLIM
• 07640167750634 - Procedure Pack: 2019-11-08 Procedure Pack 10.0 mm, 100um flap Thickness