IRIS MEDICAL IQ 810 PHOTOCOAGULATOR

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 3 2005 Mr. John Jossy Director, Regulatory Affairs and Quality Assurance Iridex Corporation 1212 Terra Bella Avenue Mountain View, California 94043-1824 Re: K040209 Trade/Device Name: IRIS Medical® IQ 810 Diode Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: II Product Code: HQF, GEX Dated: August 23,2004 Received: August 25,2004 Dear Mr. Jossy: This letter corrects our substantially equivalent letter of September 20,2004. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Mr. John Jossy Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Miriam Provost, Ph.D. Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### INDICATIONS FOR USE STATEMENT | 510(k) Number (if known): | <s>Pending</s> K 040209 | |---------------------------|-------------------------| |---------------------------|-------------------------| Device Name: IRIS Medical® IQ 810 Laser Photocoanulator Indications For Use: The WDEX IQ 810 is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation,transscleral retinal photocoagulation, iridotomy, and other laser diode treatments. The following are examples of applications for the IQ 810. | Condition | Treatment | |--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Diabetic Retinopathy Nonproliferative Retinopathy Macular Edema Proliferative Retinopathy | Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments | | Glaucoma Primary Open Angle Closed Angle Refractory Glaucoma (recalcitrant/uncontrolled) | Laser Trabeculoplasty; Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C Provost ision Sign-Off Division of General, Restorative, and Neurological Devices **510(k) Number** K040209 Prescription Use OR (Per 21 CFR 801.109) Over-The-Counter Use {3}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Pending KO 40 209 9 9 9 9 9 1 1 1 1 1 1 1 Device Name: : IRIS Medical® IQ 810 Laser Photocoagulator Indications For Use: | Condition | Treatment | |-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation<br>(TSRPC); Focal and Grid Laser Treatments | | Lattice Degeneration | PRP; Focal and Grid Laser Treatments | | Age-related Macular Degeneration (AMD)<br>with Choroidal Neovascularization (CNV) | Focal and Grid Laser Treatments | | Intra-Ocular Tumors<br>• Choroidal Hemangioma<br>• Choroidal Melanoma<br>• Retinoblastoma | Focal and Grid Laser Treatments | | Retinopathy of Prematurity | PRP; TSRPC; Focal and Grid Laser<br>Treatments | | Sub-Retinal (choroidal) Neovascularization | Focal and Grid Laser Treatments | | Central and Branch Retinal Vein Occlusion | PRP; Focal and Grid Laser Treatments | ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Provost (Division Sign-Off) Division of General, Restorative, # and Neurological Devices 510(k) (Number of Kolo209 Over-The-Counter Use _______________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________ {4}------------------------------------------------ # 510(k) Summary IRIDEX Corporation IRIS Medical® IQ 810 1/3 K046209 # Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared John Jossy IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 (650) 962-8848 ext. 3016 Contact Person: (same as above) Date Prepared: November 3, 2003 ## Name of Device and Name/Address of Sponsor IRIS Medical® IQ 810 Laser Photocoagulator IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 #### Classification Name Laser Instrument, Surgical, Powered CFR Section: 886.4390 Product Code: HQF # Predicate Devices The IQ 810 laser system is substantially equivalent to other currently legally marketed ophthalmology laser devices including IRIDEX Corporation's IRIS Medical OcuLight SLx Laser Photocoagulator (K020374). # Device Description The IQ 810 is a semiconductor diode laser system that delivers infrared 810 nm laser light intended to be used for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and iridotomy. Visible red (630-650 nm) semiconductor diode laser is used for aiming. {5}------------------------------------------------ # Intended Use The IQ 810 is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cvclophotocoagulation, transscleral retinal photocoagulation, iridotomy, and other laser diode treatments. The following are examples of applications for the IQ 810 laser systems. | Condition | Treatment | |----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Diabetic Retinopathy Nonproliferative Retinopathy Macular Edema Proliferative Retinopathy | Panretinal Photocoagulation (PRP); Focal and Grid Laser Treatments | | Glaucoma Primary Open Angle Closed Angle Refractory Glaucoma<br>(recalcitrant/uncontrolled) | Laser Trabeculoplasty; Iridotomy;<br>Transscleral Cyclophotocoagulation<br>(TSCPC) | | Retinal Tears, Detachments, and Holes | Transscleral Retinal Photocoagulation<br>(TSRPC); Focal and Grid Laser<br>Treatments | | Lattice Degeneration | PRP; Focal and Grid Laser Treatments | | Age-related Macular Degeneration (AMD)<br>with Choroidal Neovascularization (CNV) | Focal and Grid Laser Treatments | | Intra-Ocular Tumors Choroidal Hemangioma Choroidal Melanoma Retinoblastoma | Focal and Grid Laser Treatments | | Retinopathy of Prematurity | PRP; TSRPC; Focal and Grid Laser<br>Treatments | | Sub-Retinal (choroidal) Neovascularization | Focal and Grid Laser Treatments | | Central and Branch Retinal Vein Occlusion | PRP; Focal and Grid Laser Treatments | # Technological Characteristics and Substantial Equivalence The IQ 810 has substantial hardware and software differences from currently marketed laser systems. However, a detailed comparison of the key characteristics between the SLx and the IQ 810 shows that the technology of the IQ 810 does not differ significantly from the predicate device (see Section VII-A-11 of 510k Notification). {6}------------------------------------------------ The OcuLight SLx Laser System is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and iridotomy. The OcuLight SLx Laser System delivers similar power, has similar indications, and uses similar delivery devices to that of the IQ 810. #### Non-Clinical performance Data None #### Clinical performance Data None #### Conclusion The IQ 810 is substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and iridotomy.