Who is the manufacturer of Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)?

Iridex Corporation filed the 510(k) submission for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) (K230228).

What is the FDA product code for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)?

HQF. It is classified under 21 CFR 886.4390 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)

Q: What are the predicate devices for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)?

Family of IRIDEX IQ® Laser Systems (IQ532, IQ577) (K071687).

K230228 · Iridex Corporation · HQF · Feb 23, 2023 · Ophthalmic

Device Facts

Record ID	K230228
Device Name	Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
Applicant	Iridex Corporation
Product Code	HQF · Ophthalmic
Decision Date	Feb 23, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 886.4390
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Iridex® Laser Console (532 model and 577 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse) or MicroPulse® mode, for ophthalmic applications (532 and 577 models) and for Ear. Nose, and Throat (Otolaryngology) applications (532 model only).

Device Story

Solid-state laser consoles (532 nm green or 577 nm yellow) deliver laser energy via fiber optic probes to target tissues. Systems feature footswitch activation, touchscreen/knob interface, and air-cooled design. Used in physician offices, hospitals, and ambulatory surgical centers by clinicians. Operates in continuous wave or MicroPulse modes to perform photocoagulation, ablation, or hemostasis. Output energy is controlled by the clinician to achieve specific therapeutic effects on ocular or ENT tissues. Benefits include precise tissue management and treatment of various retinal and glaucomatous conditions.

Clinical Evidence

Bench testing only. No clinical data required for this product change. Testing included electrical safety (IEC 60601-1), laser safety (IEC 60601-2-22, IEC 60825-1), EMI/EMC (IEC 60601-1-2), usability (IEC 60601-1-6), software lifecycle (IEC 62304), and shipping/packaging (ISTA 3A). Internal performance specifications for power output and pulse timing were verified.

Technological Characteristics

Solid-state semiconductor laser source; 532 nm or 577 nm treatment wavelength; 650 nm aiming beam; air-cooled; footswitch-activated; fiber optic delivery; 100-240 VAC power; touchscreen/knob interface. Software-controlled embedded firmware. Non-sterile console.

Indications for Use

Indicated for soft and fibrous tissue incision, excision, coagulation, vaporization, ablation, and vessel hemostasis. 532 nm model: ENT/otolaryngology (otosclerotic hearing loss, stapedectomy, stapedotomy, myringotomies, lysis of adhesions, bleeding control, acoustic neuroma removal, soft tissue adhesion) and ophthalmology (retinal photocoagulation for diabetic retinopathy, macular edema, retinal tears/detachments, lattice degeneration, AMD, retinopathy of prematurity, sub-retinal neovascularization, retinal vein occlusion; glaucoma treatment via trabeculoplasty, iridotomy, iridoplasty). 577 nm model: Ophthalmology (photocoagulation of anterior/posterior segments, retinal/panretinal/intravitreal endophotocoagulation for vascular/structural abnormalities, glaucoma treatment).

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Predicate Devices

Family of IRIDEX IQ® Laser Systems (IQ532, IQ577) (K071687)

Related Devices

K091534 — LIGHTLAS MODEL 532 · Lightmed Corp. · Sep 18, 2009
K151109 — Lumenis Smart532 Laser System · Lumenis, Inc. · Oct 30, 2015
K072514 — VISULAS TRION · Carl Zeiss Meditec, AG · Sep 21, 2007
K181682 — VISULAS green · Carl Zeiss Meditec, AG · Mar 6, 2019
K091981 — LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER · Lightmed Corp. · Sep 28, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. February 23, 2023 Iridex Corporation Mari Iwamoto, PhD Regulatory Affairs Specialist 1212 Terra Bella Ave. Mountain View. CA 94043 Re: K230228 Trade/Device Name: Iridex® 532 Laser; Iridex® 577 Laser; Iridex® Laser (532 nm and 577 nm models) Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF, GEX Dated: January 24, 2023 Received: January 27, 2023 Dear Mari Iwamoto, PhD: 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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. 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. {1}------------------------------------------------ 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, J Angelo Green -S Image /page/1/Picture/6 description: The image shows the logo for the Food and Drug Administration (FDA). The logo is in a light blue color and is displayed on a white background. The letters "FDA" are large and bold. for Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230228 Device Name Iridex® 532 Laser Iridex® 577 Laser Iridex® Laser (532 nm and 577 nm models) #### Indications for Use (Describe) The Iridex® Laser Console (532 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse® mode, for ophthalmic applications (532 and 577 models) and for Ear, Nose, and Throat (Otolaryngology) applications (532 model only). Iridex® 532 Laser The Iridex® 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, ear, nose and throat (ENT)/otolaryngology, and ophthalmology as follows: #### Ophthalmology Indicated for retinal photocoagulation, laser trabeculoplasty, iridoplasty including: - · Retinal photocoagulation (RPC) for the treatment of - o Diabetic retinopathy, including: - Nonproliferative retinopathy - Macular edema - Proliferative retinopathy - o Retinal tears and detachments - o Lattice degeneration - o Age-related macular degeneration (AMD) - o Retinopathy of prematurity - o Sub-retinal (choroidal) neovascularization - o Central and branch retinal vein occlusion - · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including - o Primary open angle/Closed angle Ear, Nose, and Throat (ENT)/Otolaryngology Otosclerotic Hearing loss and/or diseases of the inner ear: - · Stapedectomy - · Stapedotomy - · Myringotomies - · Lysis of Adhesions - · Control of Bleeding - · Removal of Acoustic Neuromas - · Soft tissue Adhesion in Micro/Macro Otologic Procedures #### Iridex® 577 Laser The Iridex® 577 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialty of ophthalmology as follows: Ophthalmology Indicated for use in photocoagulation of both anterior and posterior segments including: - · Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural {3}------------------------------------------------ abnormalities of the retina and choroid including: o Proliferative and nonproliferative diabetic retinopathy o Choroidal neovascularization o Branch retinal vein occlusion o Age-related macular degeneration (AMD) o Retinal tears and detachments o Retinopathy of prematurity · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle on the left side, which is made up of small dots on the left half and a solid purple color on the right half. To the right of the circle is the word "IRIDEX" in purple, with each letter capitalized. ## 510(k) SUMMARY; K230228 ## Submitter Information | Company: | Iridex Corporation 1212 Terra Bella Ave Mountain View, CA 94043-1824 Phone: (650) 940-4700 Fax: (650) 940-4710 Establishment Registration No.: 2939653 | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Mari Iwamoto, PhD Specialist, Regulatory Affairs Phone: (650) 605-8727 Fax: (650) 940-4710 | - Date Prepared: February 21, 2023 ## Device Name and Classification | Common Name: | Ophthalmic Laser, Powered Laser Surgical Instrument | |----------------------|-----------------------------------------------------------------------------------| | Proprietary Name: | Iridex® 532 Laser, Iridex® 577 Laser, Iridex® Laser (532 and 577 nm models) | | Classification Name: | Laser, Ophthalmic Powered Laser Surgical Instrument | | Product Code: | HQF GEX | | Regulation Number: | 21 CFR 886.4390 21 CFR 878.4810 | | Device Class: | II | ## Predicate Device | Laser Console | | |---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company: | Iridex Corporation | | Device: | Collectively: Family of IRIDEX IQ® Laser Systems (IQ532, IQ577) (K071687) Individual Models: Iridex IQ 532® Laser System, Iridex IQ 577® Laser System | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle with a dotted outline on the left and the word "IRIDEX" in purple letters on the right. The circle is partially filled in with a solid purple color, while the other half is made up of small dots. #### Intended Use (Indications for Use) The Iridex® Laser Console (532 model and 577 model) are solid state lasers that are used to deliver laser energy in either continuous wave pulse (CW-pulse) or MicroPulse® mode, for ophthalmic applications (532 and 577 models) and for Ear. Nose, and Throat (Otolaryngology) applications (532 model only). #### Indications for Use The Iridex 532 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows: #### Ophthalmology Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including: - Retinal photocoagulation (RPC) for the treatment of ● - o Diabetic retinopathy, including: - 트 Nonproliferative retinopathy - . Macular edema - 트 Proliferative retinopathy - Retinal tears and detachments O - Lattice degeneration o - Age-related macular degeneration (AMD) O - Retinopathy of prematurity O - O Sub-retinal (choroidal) neovascularization - Central and branch retinal vein occlusion O - Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including ● - Primary open angle/Closed angle O #### Ear, Nose, and Throat (ENT)/ Otolaryngology Otosclerotic Hearing loss and/or diseases of the inner ear: - Stapedectomy - Stapedotomy - Myringotomies - Lysis of Adhesions - Control of Bleeding - Removal of Acoustic Neuromas - Soft tissue Adhesion in Micro/Macro Otologic Procedures ● {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle on the left, with a series of dots forming the left half of the circle. The right half of the circle is filled in with solid purple. To the right of the circle is the word "IRIDEX" in purple, sans-serif font. The Iridex 577 Laser is indicated for use in soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialty of ophthalmology as follows: ### Ophthalmology Indicated for use in photocoagulation of both anterior and posterior segments including: - Retinal photocoagulation, panretinal photocoagulation and intravitreal ● endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - Proliferative and nonproliferative diabetic retinopathy O - O Choroidal neovascularization - Branch retinal vein occlusion O - Age-related macular degeneration (AMD) O - Retinal tears and detachments O - Retinopathy of prematurity o - Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle ● glaucoma ### Device Description The Iridex 532/577 Laser consoles are solid state lasers that are used to deliver laser energy in continuous wave and MicroPulse® for ophthalmic applications and (for 532 only) ear, nose, and throat (ENT) / otolaryngology applications. The Iridex® 532 Laser delivers a 532 nm wavelength (green) laser emission, and the Iridex® 577 Laser delivers a 577mm wavelength (true-yellow) laser emission. The Iridex 532 Laser and the Iridex 577 Laser systems are comprised of a laser console with footswitch and an optical fiber delivery device. Each laser console model contains two laser diodes as follows: - Iridex 532 Laser: 532 nm for Treatment and 650 nm for Aiming beam ● - Iridex 577 Laser: 577 nm for Treatment and 650 nm for Aiming beam ● imaging optics, power supply, control electronics, and software/embedded firmware (with microprocessor). Lasing can only be initiated from the footswitch. Optical fiber Delivery Devices are provided separately. The following tables shows compatible delivery devices. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle on the left, with a series of dots forming the left half of the circle. The right half of the circle is filled in with solid purple. To the right of the circle is the word "IRIDEX" in purple, sans-serif font. ### Delivery Device Compatibility with SUBJECT Iridex® 532 Laser and Iridex® 577 Laser | | Iridex® 532 Laser | | Iridex 577® Laser | | |---------------------------------------------|-------------------|------------|-------------------|------------| | Delivery Device | CW-Pulse | MicroPulse | CW-Pulse | MicroPulse | | EndoProbe | ● | | ● | | | Laser Indirect Ophthalmoscopes (LIO) | | | | | | ● Iridex LIO Plus (Single-Mirror) | ● | | ● | | | ● TruFocus LIO Premiere (Dual Mirror) | ● | | ● | | | TxCell™ Scanning Laser Delivery System | ● | ● | ● | ● | | Slit Lamp Adapters (SLA) | ● | ● | ● | ● | | ENT Devices | | | | | ### Comparison of Technological Characteristics with the Predicate Device The following table provides a comparison of Technological Characteristics of the SUBJECT device (Iridex® 532 Laser and Iridex® 577 models) to the PREDICATE Devices (Iridex IQ 532® Laser System, Iridex IQ 577® Laser System). The technological characteristics of the SUBJECT device (laser console) are substantially equivalent to those of the PREDICATE device (laser console and compatible delivery device). {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for IRIDEX. The logo consists of a purple circle made of dots on the left, followed by the word "IRIDEX" in purple. The font is sans-serif and the letters are evenly spaced. | Characteristic | Family of IRIDEX IQ® Laser Systems, IQ532, IQ577 models (PREDICATE Device) | Iridex 532 Laser / Iridex 577 Laser (Subject Device) | Bearing on Substantial Equivalence | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------| | Intended Use and Indications for Use | | | | | Intended Use and Indications for Use | The Iridex® 532 Laser and Iridex® 577 Laser and the hand pieces, delivery devices and accessories that are used with them to deliver laser energy in either CW-pulse or MicroPulse mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of ear, nose and throat (ENT)/otolaryngology, and ophthalmology as follows: 532 nm Ear, Nose, and Throat (ENT)/ Otolaryngology Otosclerotic Hearing loss and/or diseases of the inner ear: Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft tissue Adhesion in Micro/Macro Otologic Procedures Ophthalmology Indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, iridoplasty including: Retinal photocoagulation (RPC) for the treatment of: Diabetic retinopathy, including: Nonproliferative retinopathy Macular edema Proliferative retinopathy Retinal tears and detachments Lattice degeneration Age-related macular degeneration (AMD) Retinopathy of prematurity Sub-retinal (choroidal) neovascularization Central and branch retinal vein occlusion Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including Primary open angle/Closed angle 577 nm Ophthalmology Indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroids including: Proliferative and nonproliferative diabetic retinopathy; Choroidal neovascularization; Branch retinal vein occlusion; Age-related macular degeneration (AMD); Retinal tears and detachments; Retinopathy of prematurity; Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma | Identical (no change) | Substantially Equivalent | | Characteristic | Family of IRIDEX IQ® Laser Systems, IQ532, IQ577 models (PREDICATE Device) | Iridex 532 Laser / Iridex 577 Laser (Subject Device) | Bearing on Substantial Equivalence | | Where the device is used | Physician's office, hospital operating room and ambulatory surgical center setting hospital, eye clinic or doctor's exam room | Identical (no change) | Substantially Equivalent | | | Principles of Operation (technology) | | | | Technological Characteristics | The light energy delivered for treatment is from a 532 nm (for IQ 532 Laser) or 577 nm (for IQ 577 Laser) semiconductor laser source, with up to 5 W of output power. The light is delivered to the treatment site with fiber optic treatment probes and accessories. | Identical (no change) | Substantially Equivalent | | | The power source for the console is standard utility outlets | | | | | Design/Technological Characteristics | | | | Operating Principles | A laser console that plugs into standard utility outlets, connects to a footswitch for activation control and uses a delivery probe/accessory attached to the probe port to deliver the light. The console has a user interface to adjust system settings. | Identical (no change) | Substantially Equivalent | | Design Characteristics | Hardware: A sheet metal enclosure with front bezel and back panel. An approved power supply, control board, laser module driver, laser module, user interface, power cord and foot switch. Laser activation: Footswitch Cooling System: Air Cooled | Identical (no change) | Substantially Equivalent | | Output Mode | Continuous-Wave and MicroPulse | Identical (no change) | Substantially Equivalent | | Electrical VAC | 100-240 VAC, 50/60 Hz | Identical (no change) | Substantially Equivalent | | Electrical Current | < 3 amps | Updated to meet regulatory requirements | Substantially Equivalent | | User Interface | Touchscreen with Keyboard, Knobs on Laser Console, Remote Control, Footswitch | Identical, but Remote Control is not planned to be provided | Substantially equivalent | | Laser Activation | Footswitch | Identical with addition of currently marketed wired footswitches (cleared in 510(k) K151890 and K160549) | Substantially Equivalent | | Characteristic | Family of IRIDEX IQ® Laser Systems, IQ532, IQ577 models (PREDICATE Device) | Iridex 532 Laser / Iridex 577 Laser (Subject Device) | Bearing on Substantial Equivalence | | Performance | | | | | Treatment wavelength (Nominal) | For the 532 nm Laser: • 532 nm For the 577 nm Laser: • 577 nm | Identical (no change) | Substantially Equivalent | | Aiming beam wavelength (Nominal) | 635 nm laser diode. User-adjustable | Identical (no change) | Substantially Equivalent | | Maximum laser power | 5 W (treatment) | Reduced Maximum Laser Power to 2.5 W | Substantially Equivalent | | Treatment laser power | For the Iridex 532 Laser: 50 - 2500 mW (delivered), depending on delivery device. XP Option: 0 - 5000 mW (delivered) For the Iridex 577 Laser: 50 - 2000 mW (delivered), depending on delivery device. Option to maximum of 2.5 W | For the Iridex 532 Laser: 50 - 2500 mW (delivered), depending on delivery device. For the Iridex 577 Laser: 50 - 2000 mW (delivered), depending on delivery device. Option to maximum of 2.5 W Identical, however XP Option is not Offered | Substantially Equivalent | | Maximum aiming beam power | < 1 mW (aiming) | Identical (no change) | Substantially Equivalent | | Continuous Wave duration | 10 ms – 10000 ms or CW to 60 seconds | Tightened the maximum CW Pulse, which remains within the original duration specification as follows: 10 ms – 3000 ms or CW to 60 seconds | Substantially Equivalent | | Characteristic | Family of IRIDEX IQ® Laser Systems, IQ532, IQ577 models (PREDICATE Device) | Iridex 532 Laser / Iridex 577 Laser (Subject Device) | Bearing on Substantial Equivalence | | MicroPulse duration | 0.025 ms – 1.0 ms…