FDA.reportPublic FDA data

ALLY

Primary DI
10867744000157
Brand
ALLY
Company
LENSAR, LLC
Model
70-00050-001
Catalog number
N/A
Published
2023-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOEOphthalmic Femtosecond Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOEOphthalmic Femtosecond LaserOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220259000ALLY Adaptive Cataract Treatment SystemLensar, Inc.2022-06-09OOE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10867744000157PackageGS11In Commercial Distribution
00867744000150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086774400015710867744000157
00867744000150008677440001508677440001500867744000150

GMDN Terms#

Term, Definition table
TermDefinition
Femtosecond ophthalmic solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for ocular resections and incisions (cataract incisions, arcuate corneal/scleral cuts/tunnels, anterior capsulotomy, phacofragmentations, corneal flaps, lamellar/perforating keratoplasty). The system includes a beam delivery device, imaging device, computer, software and controls; it cuts by micro-photodisruption of tissue created by focused ultra-short [femtosecond (FS)] pulses; it does not include fundus imaging technology and the therapeutic laser is not frequency-doubled.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure57.2 KiloPascal101 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080387995
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10867744000102LENSAR LLS-fs 3D70-00005-0012016-09-24
10867744000119LENSAR LLS-fs 3D70-00013-0012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850062486027LLS/ALLYLENSAR, Inc.OOE2026-04-13
00867744000167LLS/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
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