FDA.reportPublic FDA data

LIQUID OPTICS INTERFACE

Primary DI
05050474609778
Brand
LIQUID OPTICS INTERFACE
Company
JOHNSON & JOHNSON SURGICAL VISION, INC.
Model
0180-1201
Catalog number
0180-1201
Device description
LIQUID OPTICS INTERFACE, SIZE 12, GEN2
Published
2018-06-08
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170322000Catalys Precision Laser SystemAbbott Medical Optics, Inc.2017-05-19OOE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05050474609778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05050474609778050504746097785050474609778

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity080 Percent (%) Relative Humidity
Handling Environment Temperature055 Degrees Celsius
Storage Environment Humidity080 Percent (%) Relative Humidity
Storage Environment Temperature055 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)266-4543JJV-US-SURGICALORDERS@ITS.JNJ.COM

Regulatory Flags#

DUNS number
010130626
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05050474806153PURESEE IOLDEN00VDEN00VU0502026-03-16
05050474806160PURESEE IOLDEN00VDEN00VU0552026-03-16
05050474806177PURESEE IOLDEN00VDEN00VU0602026-03-16
05050474806184PURESEE IOLDEN00VDEN00VU0652026-03-16
05050474806191PURESEE IOLDEN00VDEN00VU0702026-03-16
05050474806207PURESEE IOLDEN00VDEN00VU0752026-03-16
05050474806214PURESEE IOLDEN00VDEN00VU0802026-03-16
05050474806221PURESEE IOLDEN00VDEN00VU0852026-03-16
05050474806238PURESEE IOLDEN00VDEN00VU0902026-03-16
05050474806245PURESEE IOLDEN00VDEN00VU0952026-03-16
05050474806252PURESEE IOLDEN00VDEN00VU1002026-03-16
05050474806269PURESEE IOLDEN00VDEN00VU1052026-03-16
05050474806276PURESEE IOLDEN00VDEN00VU1102026-03-16
05050474806283PURESEE IOLDEN00VDEN00VU1152026-03-16
05050474806290PURESEE IOLDEN00VDEN00VU1202026-03-16
05050474806306PURESEE IOLDEN00VDEN00VU1252026-03-16
05050474806313PURESEE IOLDEN00VDEN00VU1302026-03-16
05050474806320PURESEE IOLDEN00VDEN00VU1352026-03-16
05050474806337PURESEE IOLDEN00VDEN00VU1402026-03-16
05050474806344PURESEE IOLDEN00VDEN00VU1452026-03-16

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
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