FDA.reportPublic FDA data

IRIDEX 810 Laser

Primary DI
00813125016654
Brand
IRIDEX 810 Laser
Company
IRIDEX CORPORATION
Model
22000
Device description
The Iridex 810 Laser is a semiconductor diode laser system that delivers pulsed 810nm infrared laser light intended to be used for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other laser diode treatments.
Published
2021-03-10
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
K202760000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202760000Iridex 810 LaserIridex Corporation2020-10-21HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813125016654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813125016654008131250166548131250166540813125016654

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemA mains electricity (AC-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.

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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