FDA.reportPublic FDA data

Assy, Top Zeiss 120 SLA 577nm

Primary DI
00813125016500
Brand
Assy, Top Zeiss 120 SLA 577nm
Company
IRIDEX CORPORATION
Model
66274
Published
2017-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQFLaser, OphthalmicOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813125016500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813125016500008131250165008131250165000813125016500

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

Regulatory Flags#

DUNS number
612920785
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03830074980017MR Q Meridian Medical d.o.o.HQF2025-10-20
03830074980024MR Q SLTMeridian Medical d.o.o.HQF2025-10-20
03830074980048Merilas Meridian Medical d.o.o.HQF2025-10-20
07290110123741Alma Pixel 30W 120V 50/60Hz Black (Inc)ALMA LASERS LTD.HQF2025-08-11
07290018686058Voyager DSLTBELKIN VISION LTDHQF2025-07-16
07290110123680Pixel CO2 30W 120V 50/60Hz Black (Inc)ALMA LASERS LTD.HQF2025-07-08
03700542625958CAPSULOQUANTEL MEDICALHQF2025-03-25
05700002165466Norlase LYNX photocoagulatorNorlase ApSHQF2024-10-30
00813125010249Eye Safety Filter, Fixed (532 nm) IRIDEX CORPORATIONHQF2024-10-22
00813125010256Eye Safety Filter, Fixed (532 nm)IRIDEX CORPORATIONHQF2024-10-22
00813125010263Eye Safety Filter, Two-Position (532 nm)IRIDEX CORPORATIONHQF2024-10-22
00813125010270Eye Safety Filter, Two-Position (532 nm)IRIDEX CORPORATIONHQF2024-10-22
00813125014490Eye Safety Filter, Two-Position (577 nm)IRIDEX CORPORATIONHQF2024-10-22
00813125014506Eye Safety Filter, Two-Position (577 nm)IRIDEX CORPORATIONHQF2024-10-22
00813125014513Eye Safety Filter, Two-Position (532 nm)IRIDEX CORPORATIONHQF2024-10-22
00813125014520Eye Safety Filter, Two-Position (532 nm)IRIDEX CORPORATIONHQF2024-10-22
00813125015039Eye Safety Filter, Fixed (577 nm)IRIDEX CORPORATIONHQF2024-10-22
00813125017149Eye Safety Filter, Fixed (532 nm) IRIDEX CORPORATIONHQF2024-10-22
00813125017163Eye Safety Filter, Fixed (577 nm)IRIDEX CORPORATIONHQF2024-10-22
00813125017170Eye Safety Filter, Fixed (577 nm) IRIDEX CORPORATIONHQF2024-10-22
00813125010188Eye Safety Filter, Fixed (810 nm)IRIDEX CORPORATIONHQF2024-10-21
00813125010195Eye Safety Filter, Fixed (810 nm)IRIDEX CORPORATIONHQF2024-10-21
00813125017118Eye Safety Filter, Fixed (810 nm) IRIDEX CORPORATIONHQF2024-10-21
00813125017125Eye Safety Filter, Fixed (810 nm) IRIDEX CORPORATIONHQF2024-10-21
00813125017132Eye Safety Filter, Fixed (532 nm) IRIDEX CORPORATIONHQF2024-10-21
00813125017156Eye Safety Filter, Fixed (532 nm)IRIDEX CORPORATIONHQF2024-10-21
07290018686027Eagle BELKIN VISION LTDHQF2024-07-31
10380650002362UNITY TETRASPOTAlcon Laboratories, Inc.HQF2024-07-03