FDA.reportPublic FDA data

Integre Pro Yellow

Primary DI
09342395000120
Brand
Integre Pro Yellow
Company
ELLEX MEDICAL PTY LTD
Model
LP561
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081565000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081565000INTEGRE PRO, MODEL L2RYEllex Medical Pty, Ltd.2008-07-02HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09342395000120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09342395000120093423950001209342395000120

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic solid-state laser system, photocoagulation/photostimulationAn electrically-powered device assembly with a solid-state laser (exited glass/crystal rod), that might be designed to optionally utilize the diode pump laser as a direct therapeutic laser, intended for: 1) ocular photocoagulation-based procedures (e.g., coagulate abnormal vascular tissue in the retina); and/or 2) dosimetery-controlled photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration; it might additionally be intended for iridectomy. It may include a built-in slit lamp and a dosimetry sensor, however, it does not include femtosecond pulsing or fundus imaging technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
756138509
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09342395000106Integre Pro Red/GreenLP1RG2016-09-24
09342395000588Ellex63289902016-09-24
09342395000502EllexTS_ACCESS2023-06-09
09342395000519EllexTS_ACCESS-MOBILE2023-06-09
09342395000526EllexTS_MOBILE2023-06-09
09342395000540EllexCOLUMN_HV2023-06-09
09342395000557EllexCOLUMN_LV2023-06-09
0934239500227840MHZKIT-USA40MHZ ACCESSORY KIT-USA2024-11-26
09342395002285ACC0004240MHz Probe International Accessory Kit2024-11-26
09342395001370Eye Cubed V4 New GenI3 SYSTEM-ABDU2016-09-24
09342395000038UltraQ ReflexLQP3106-U2016-09-24
09342395000175Solitaire LP45322016-09-23
09342395000199SOLITAIRE LP45322016-09-24
09342395000069SoloLT5106-S2016-09-24
09342395000113TangoLT5106-T2016-09-23
09342395000137UltraQLQP3106-U 2016-09-24
093423950002122RTLR15322016-09-24
09342395000090Integre ProLP55322016-09-24
09342395000144Integre Pro Scan Red-GreenLP6RG2016-03-02
09342395000151Integre Pro Scan Red-YellowLP6RY2016-09-24

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