FDA.reportPublic FDA data

LLS/ALLY

Primary DI
00867744000167
Brand
LLS/ALLY
Company
LENSAR, Inc.
Model
70-00044-001
Catalog number
70-00044-001
Device description
Patient Interface Device-Elliptical
Published
2026-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOEOphthalmic Femtosecond Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOEOphthalmic Femtosecond LaserOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10867744000164PackageGS120In Commercial Distribution
20867744000161PackageGS14In Commercial Distribution
30867744000168PackageGS110In Commercial Distribution
00867744000167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086774400016410867744000164
2086774400016120867744000161
3086774400016830867744000168
00867744000167008677440001678677440001670867744000167

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic laser system eyeball positioning suction cupA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-29 Degrees Celsius59 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
888-536-7271service@lensar.com

Regulatory Flags#

DUNS number
004071212
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850062486027LLS/ALLY70-00036-00170-00036-0012026-04-13
00867744000174LLS/ALLY70-00046-00170-00046-0012026-04-13
00867744000181ALLY70-00055-00170-00055-0012026-04-13
00867744000105LENSAR LLS-fs 3D70-00005-0012016-09-24
00867744000112LENSAR LLS-fs 3D70-00013-0012016-09-24
00867744000150ALLY70-00050-001N/A2023-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850062486027LLS/ALLYLENSAR, Inc.OOE2026-04-13
00867744000174LLS/ALLYLENSAR, Inc.OOE2026-04-13
00867744000181ALLYLENSAR, Inc.OOE2026-04-13
00380650009449LenSxAlcon Laboratories, Inc.OOE2025-10-01
04050555002086Patient Interface 125 KitTechnolas Perfect Vision GmbHOOE2024-03-13
00867744000150ALLYLENSAR, Inc.OOE2023-08-18
10867744000157ALLYLENSAR, LLCOOE2023-08-18
05050474655690INTRALASE TECHNOLOGY PIJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2023-08-11
05050474655706INTRALASE TECHNOLOGY PIJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2023-08-11
05050474738553ELITAJOHNSON & JOHNSON SURGICAL VISION, INC.OOE2023-08-11
07640167750573FEMTOSIE AG, Surgical Instrument EngineeringOOE2022-06-10
07640167751334Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751341Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751358Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751365Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751372Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
07640167751389Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2020-12-22
05050474709508CATALYS SYSTEMOPTIMEDICA CORPORATIONOOE2020-08-19
07640167750511Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750528Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750542Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750566Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750580Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750603Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167750627Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751051Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751068Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751082Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751143Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14
07640167751129Procedure Pack Z8SIE AG, Surgical Instrument EngineeringOOE2018-09-14