FDA.reportPublic FDA data

Iridex 577 Laser

Primary DI
00813125015381
Brand
Iridex 577 Laser
Company
IRIDEX CORPORATION
Model
24000
Device description
The Iridex® 577 (577 nm, true-yellow) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-Wave and MicroPulse® modes for ophthalmic applications.
Published
2024-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
HQFLaser, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230228000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230228000Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)Iridex Corporation2023-02-23HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813125015381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813125015381008131250153818131250153810813125015381

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 388-4747customerservice@iridex.com

Regulatory Flags#

DUNS number
612920785
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813125010249Eye Safety Filter, Fixed (532 nm) 307752024-10-22
00813125010256Eye Safety Filter, Fixed (532 nm)312602024-10-22
00813125010263Eye Safety Filter, Two-Position (532 nm)304942024-10-22
00813125010270Eye Safety Filter, Two-Position (532 nm)304932024-10-22
00813125014490Eye Safety Filter, Two-Position (577 nm)654722024-10-22
00813125014506Eye Safety Filter, Two-Position (577 nm)654732024-10-22
00813125014513Eye Safety Filter, Two-Position (532 nm)654742024-10-22
00813125014520Eye Safety Filter, Two-Position (532 nm)654752024-10-22
00813125015039Eye Safety Filter, Fixed (577 nm)655512024-10-22
00813125017149Eye Safety Filter, Fixed (532 nm) 303672024-10-22
00813125017163Eye Safety Filter, Fixed (577 nm)654702024-10-22
00813125017170Eye Safety Filter, Fixed (577 nm) 654712024-10-22
00813125010188Eye Safety Filter, Fixed (810 nm)131072024-10-21
00813125010195Eye Safety Filter, Fixed (810 nm)140802024-10-21
00813125017118Eye Safety Filter, Fixed (810 nm) 103782024-10-21
00813125017125Eye Safety Filter, Fixed (810 nm) 111752024-10-21
00813125017132Eye Safety Filter, Fixed (532 nm) 303662024-10-21
00813125017156Eye Safety Filter, Fixed (532 nm)303642024-10-21
00813125010584OMA (810 nm)134112024-05-06
00813125010591OMA (810 nm)116712024-05-06

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