BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Iridex Corporation

    Reg #: 2939653 · FEI: 2939653 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    41
    Establishment Types
    2
    Classifications
    10

    Registration Details

    Registration Name
    Iridex Corporation
    Registration Number
    2939653
    FEI Number
    2939653
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1212 Terra Bella Avenue
    City
    MOUNTAIN VIEW
    State
    CA
    ZIP
    94043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071687

    Owner / Operator

    Firm Name
    Iridex Corporation
    Operator Number
    9001789
    Address
    1212 Terra Bella Avenue, --
    City
    Mountain View
    State
    CA
    Postal Code
    94043
    Country
    US

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Table, Instrument, Powered, Ophthalmic HRJ
    Laser, Ophthalmic HQF
    Lens, Contact, Polymethylmethacrylate, Diagnostic HJK
    Projector, Ophthalmic HOS
    Cannula, Ophthalmic HMX
    Endoilluminator MPA
    Device, Irrigation, Ocular Surgery KYG
    Instrument, Manual, Surgical, General Use MDM
    Biomicroscope, Slit-Lamp, Ac-Powered HJO

    Proprietary Names

    Instrument table Iridex 810 Laser PASCAL Photocoagulator, Product-PASCAL-01 TruFocus LIO Premiere PASCAL Streamline Photocoagulator G-Probe Illuminate PASCAL Streamline 577 PSLT for PASCAL Streamline PASCAL Photocoagulator, PASCAL-US Head-Up-Display, HUD-1 PSLT with PASCAL Synthesis and PASCAL Synthesis TwinStar GreenTipTM Soft Tip Cannula  25 Gauge Brush Tip Length: 2.5 MM  Box (Qty 12) 10 Pack Box, 23 Ga Cannula, GreenTip, Soft Tip 0.5 mm GreenTipTM Soft Tip Cannula  23 Gauge Tip Length: 1 MM  Box (Qty 12) GreenTipTM Soft Tip Cannula  23 Gauge Brush Tip Length: 0.5 MM  Box (Qty 12) GreenTipTM Soft Tip Cannula  23 Gauge Brush Tip Length: 2.5 MM  Box (Qty 12) GreenTipTM Soft Tip Cannula  20 Gauge Tip Length: 1 MM  Box (Qty 12) GreenTipTM Soft Tip Cannula  23 Gauge Tip Length: 2.5 MM  Box (Qty 12) GreenTipTM Soft Tip Cannula  25 Gauge Tip Length: 0.5 MM  Box (Qty 12) 10 Pack Box, 23 Ga Cannula, Green Tip, Soft Tip 1 Mm 10 Pack Box, 25 Ga Cannula, Green Tip, Soft Tip 1 Mm GreenTipTM Soft Tip Cannula  20 Gauge Brush Tip Length: 2.5 MM  Box (Qty 12) GreenTipTM Soft Tip Cannula  20 Gauge Tip Length: 0.5 MM  Box (Qty 12) 10 Pack Box, 25 Ga Cannula, GreenTip, Soft Tip 0.5 Mm GreenTipTM Soft Tip Cannula  25 Gauge Tip Length: 1 MM  Box (Qty 12) GreenTipTM Soft Tip Cannula  25 Gauge Tip Length: 2.5 MM  Box (Qty 12) Green Tip PASCAL Synthesis Delivery System Iridex PASCAL 532 Iridex PASCAL 577 OcuLight SL/SLx Iridex 577 Laser Iridex 532 Laser Pascal Synthesis Light Pipe GreenTipTM Surgical Scraper , 23 GA & 25 GA Iridex Wireless Footswitch PASCAL Laser Indirect Ophthalmoscope Slit lamp Biomicroscope Laser Indirect Ophthalmoscope Pascal Synthesis TwinStar Ophthalmic Scanning Laser System

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device