LenSx

GUDID 00380659981623

LenSx Laser System

Alcon Laboratories, Inc.

Femtosecond ophthalmic solid-state laser system Femtosecond ophthalmic solid-state laser system

• Primary Device ID: 00380659981623
• NIH Device Record Key: 56afe69f-071f-4728-be5a-6e9562800001
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LenSx
• Version Model Number: 8065998162
• Company DUNS: 008018525
• Company Name: Alcon Laboratories, 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(800)862-5266
• Email: web.masterus@alcon.com
• Phone: +1(800)862-5266
• Email: web.masterus@alcon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380659981623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123120

FDA Product Code

• OOE: Ophthalmic femtosecond laser

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: 2019-09-02
• Device Publish Date: 2016-09-24

On-Brand Devices [LenSx]

• 00380659981623: LenSx Laser System
• 10380650000573: LENSXPATIENT INTERFACE FLAP 10PK,EO
• 20380650000563: LENSX SOFTFIT PATIENT INTERFACEI FLAT,EO
• 20380650000556: LENSX SOFTFIT PATIENT INTERFACE STEEP,EO
• 20380650000549: LENSX SOFTFIT PATIENT INTERFACE NOMINAL,EO
• 10380650000535: LENSX LASER SOFTFIT PATIENT INTERFACE 10 PK, EO