ALLY

Basic Information

• Brand Name: ALLY
• Primary DI: 00867744000181
• Version / Model: 70-00055-001
• Catalog Number: 70-00055-001
• Company Name: LENSAR, Inc.
• Labeler DUNS: 004071212
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-13
• Public Version: 1
• Public Version Date: 2026-04-21
• Public Version Status: New
• Public Device Record Key: 41bd7e5e-8e9b-4af9-a3a0-446c14e0c51c

Device Description

Drapes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	886.4390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment/instrument drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10867744000188	GS1	Shelf Box	10	In Commercial Distribution
Primary	00867744000181	GS1
Package	20867744000185	GS1	Shipping Carton	4	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K220259	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -29 – 59 Degrees Celsius