Iridex Corporation

FDA Device Registration & Listing · MOUNTAIN VIEW, CA, US · Registration 2939653

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2939653
FEI Number
2939653
Entity Name
Iridex Corporation
City/State/Country
MOUNTAIN VIEW, CA, US
Establishment Address
1212 Terra Bella Avenue, MOUNTAIN VIEW, CA 94043, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Iridex Corporation (Owner Number: 9001789)
Owner / Operator Contact Address
1212 Terra Bella Avenue, --, Mountain View, CA 94043, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K123056
PMA Number
N/A

All Registered 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 TruFocus LIO Premiere PASCAL Streamline Photocoagulator 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-12-17
HRJ Table, Instrument, Powered, Ophthalmic Ophthalmic Class 1 886.4855 2019-03-08
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-01-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-12-28
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2020-12-28
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-09-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-02-26
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2021-09-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2017-03-16
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2021-09-15
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2021-09-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-03
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic Ophthalmic Class 2 886.1385 2010-12-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-09-15
HOS Projector, Ophthalmic Ophthalmic Class 1 886.1680 2021-09-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-03
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2021-09-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-09-15
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2010-12-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-09-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-09-07
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2021-09-15
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2022-12-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-03
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2008-03-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-03
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2008-03-03
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2023-04-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-04-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2015-10-26
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2021-09-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-09-15
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2010-12-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-03-03
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2010-12-27
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-09-12
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2024-12-10
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2008-03-03
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2021-09-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Iridex Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0011-2019 Ellex iScience, Inc. 1
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009 Becton Dickinson and Company 1
BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2939653. Last updated year: 2026. Please use registration number 2939653 when referencing this establishment in official correspondence.
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