LenSx® SoftFit™

Basic Information

• Brand Name: LenSx® SoftFit™
• Primary DI: 00380659982767
• Version / Model: 8065998276
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 5
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: cdad5af8-35cc-4938-9ef0-6e415d6561e2

Device Description

LenSx® SoftFit™ Patient Interface Flat

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQC	Unit, phacofragmentation	Ophthalmic	886.4670	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65747	Ophthalmic laser system eyeball positioning suction cup	A non-powered device intended to orient and fix the eyeball in a desired position relative to an ophthalmic laser system beam guide during ophthalmic laser surgery. It is designed as a laser-interfacing suction cup intended to contact and stabilize the eyeball via suction controlled by the laser system; it may also include a treatment contact lens. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380659982767	GS1
Package	20380659982761	GS1		60	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]