(27 days)
No
The summary describes a laser console for delivering laser energy for surgical procedures. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies focus on electrical, laser, and software safety, not AI/ML performance metrics.
Yes
The device is used for medical specialties like ophthalmology and ENT to treat various conditions, including chronic diseases, directly impacting patient health and well-being.
No
This device is a therapeutic device that delivers laser energy for treatment applications such as incision, excision, coagulation, vaporization, ablation, and vessel hemostasis, rather than for diagnosis.
No
The device description explicitly states that the system is comprised of a laser console with footswitch and an optical fiber delivery device, in addition to software/embedded firmware. This indicates the presence of significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Iridex Laser Console is a surgical laser system used to deliver energy directly to tissues within the body for treatment purposes (incision, excision, coagulation, vaporization, ablation, hemostasis). It is used in ophthalmology and ENT procedures.
- Lack of Specimen Analysis: The description and intended use clearly indicate that the device operates directly on the patient's tissues and does not involve the analysis of in vitro specimens.
Therefore, the Iridex Laser Console falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
- o Diabetic retinopathy, including:
- · 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
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
Product codes (comma separated list FDA assigned to the subject device)
HQF, GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear, Nose, and Throat (ENT)/Otolaryngology, Ophthalmology (Retina, Choroid, Angle)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician's office, hospital operating room and ambulatory surgical center setting hospital, eye clinic or doctor's exam room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing was performed to relevant standards, including IEC 60601-1 (Electrical Safety), IEC 60601-2-22 (Laser Safety), IEC 60825-1 (Laser Safety), IEC 60601-1-2 (EMI/EMC), IEC 60601-1-6 (Usability), and IEC 62304 (Medical device software, Software life-cycle processes). All external standard tests passed. Internal specifications for Treatment Beam Power Output, Pulse Duration/Interval (MicroPulse Mode), Pulse Duration/Interval (Continuous-Wave Mode), and Aiming Beam Power Output were also tested and passed. Software Verification/Validation tasks were performed consistent with IEC 62304, and all five Software V&V Domains passed (Product Info Domain, Essential (Basic) Function Domain, Setting Domain, Specials Domain, and Safety Domain). Clinical testing was not required for this product change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 886.4390 Ophthalmic laser.
(a)
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.(b)
Classification. Class II.
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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
- o Diabetic retinopathy, including:
- · 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)
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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 |
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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
- o Diabetic retinopathy, including:
- 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 ●
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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.
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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).
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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 |