Iridex TruFocus LIO Premiere

K170718 · Iridex Corporation · GEX · May 3, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170718
• Device Name: Iridex TruFocus LIO Premiere
• Applicant: Iridex Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulseTM or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows: 532 nm: Dermatology: - Pigmented Skin Lesions - Vascular Lesions 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, 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 577nm Dermatology: - Treatment of Vascular and pigmented lesions 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; - Choroidal neovascularization: - Branch retinal vein occlusion; - Age-related macular degeneration - Retinal tears and detachments - Retinopathy of prematurity - · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma 630 - 670nm 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 non-proliferative diabetic retinopathy; - Choroidal neovascularization: - Branch retinal vein occlusion: - Age-related macular degeneration - Retinal tears and detachments - Retinopathy of prematurity - · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma 810nm Ophthalmology: Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples: - Retinal photocoagulation for the treatment of: - Diabetic retinopathy, including: - Nonproliferative retinopathy - Macular edema - Proliferative retinopathy - Retinal Tears, Detachments and Holes - Lattice degeneration - Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) - Retinopathy of prematurity - Sub-retinal (choroidal) neovascularization - Central and Branch Retinal Vein Occlusion - Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including: - Primary open angle - Closed angle - Refractory Glaucoma (recalcitrant/uncontrolled)

Device Story

Head-mounted laser indirect ophthalmoscope (LIO) used with Iridex IQ laser systems; delivers laser energy (532nm, 577nm, 630-670nm, 810nm) via fiber optics for transpupillary photocoagulation. Used by ophthalmologists to visualize peripheral retina and perform treatments on patients, including infants, in supine position. Device features binocular visualization, LED illumination (optional halogen), and air-cooled design. Connects to laser console; utilizes RFID for laser-to-device communication. Output is focused laser energy for tissue coagulation, vaporization, or ablation. Benefits include precise retinal treatment and versatility across ophthalmic, dermatologic, and ENT procedures.

Clinical Evidence

Bench testing only. Compliance with ISO 15004-2 (ophthalmic instruments), IEC 60601-1 (electrical safety), IEC 60601-2-22 (laser surgical equipment), IEC 60825-1 (laser safety), IEC 60601-1-6, and IEC 62366 (usability) demonstrated safety and effectiveness.

Technological Characteristics

Headband-mounted binocular indirect ophthalmoscope; LED illumination (optional halogen); air-cooled; fiber optic delivery; 370mm working distance; 1.1mm/4.0mm spot sizes. Powered by Heine rechargeable battery (100-240VAC). Standards: ISO 15004-2, IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 62366.

Indications for Use

Indicated for patients requiring laser photocoagulation, trabeculoplasty, iridotomy, or iridoplasty for ocular conditions including diabetic retinopathy, macular edema, retinal tears/detachments, AMD, retinopathy of prematurity, and glaucoma. Also indicated for dermatology (vascular/pigmented lesions) and ENT (otosclerotic hearing loss, stapedectomy, stapedotomy, myringotomies, lysis of adhesions, bleeding control, acoustic neuroma removal).

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Iridex TruFocus LIO+ Laser Indirect Ophthalmoscope (K071687)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2017

Iridex Corporation Gloria Dy Regulatory Compliance Associate 1212 Terra Bella Avenue Mountain View, CA 94043-1824

Re: K170718

Trade/Device Name: Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: March 7, 2017 Received: March 9, 2017

Dear Gloria Dy:

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. 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.

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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): medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170718

#### Device Name

Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532m], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories

#### Indications for Use (Describe)

The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577mm], IQ 630-670 [630mm-670mm], IQ 810 [810mm]), hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, M or LongPulse TM mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:

532 nm:

Dermatology:

- · Pigmented Skin Lesions
- · Vascular Lesions

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

#### 577nm

Dermatology:

- · Treatment of Vascular and pigmented lesions
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;

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- Choroidal neovascularization;
- Branch retinal vein occlusion;
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

## 630 - 670nm

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 non-proliferative diabetic retinopathy;
- Choroidal neovascularization:
- Branch retinal vein occlusion;
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma

## 810nm

Ophthalmology:

Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:

- Retinal photocoagulation for the treatment of:
- Diabetic retinopathy, including:
- Nonproliferative retinopathy

Macular edema

Proliferative retinopathy

- Retinal Tears, Detachments and Holes
- Lattice degeneration
- Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
- Retinopathy of prematurity
- Sub-retinal (choroidal) neovascularization
- Central and Branch Retinal Vein Occlusion

- Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:

- Primary open angle
- Closed angle
- Refractory Glaucoma (recalcitrant/uncontrolled)

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

## Summary prepared on Date: April 27, 2017

#### 510(k) Submitter/Holder:

Iridex Corporation 1212 Terra Bella Avenue Mountain View, CA 94043

# Contact:

Gloria Dy Regulatory Compliance Associate Telephone: [phone] Fax: [phone] Email: [e-mail]

# Name of Device:

Trade Name: Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IO 577 [577nm], IQ 630-670 [630mm-670mm], hand pieces, delivery devices & accessories

| Common Name: | Laser Indirect Ophthalmoscope |
|----------------------|------------------------------------------------------|
| Classification Name: | Laser Powered Surgical Instruments (and Accessories) |

# Predicate Device:

| Trade Name: | Iridex TruFocus LIO+ Laser Indirect Ophthalmoscope |
|----------------------|------------------------------------------------------|
| Common Name: | Laser Indirect Ophthalmoscope |
| Classification Name: | Laser Powered Surgical Instruments (and Accessories) |
| 510(k) Number: | K071687 |
| Manufacturer: | IRIS Medical Instruments, Inc. /Iridex Corporation |

# Device Description:

Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630mm-670mm], and IQ 810 [810mm]), hand pieces, delivery devices & accessories is a delivery accessory used with the Iridex family of IQ laser systems (IQ532, IQ577, and IQ810). Iridex TruFocus LIO Premiere and the Family of Iridex® IO Laser Systems (10 532 1532nm), 10 577 [577mm], IQ 630-670 [630nm-670mm], IQ 810 [810nm]), hand pieces, delivery devices & accessories is a headmounted diagnostic indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient's retina. It allows binocular visualization of the peripheral retina not easily viewed at the slit lamp and can be used to evaluate and treat patients, including infants, while they are in a supine position.

Premarket Notification Traditional 510(k) Page 1 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories

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The LIO is a laser delivery device used to perform transpupillary laser photocoagulation during noninvasive ocular surgical procedures. The LIO is supplied non-sterile and is intended for reuse.

Variants of the device may relate to the style of headband, laser wavelength to be delivered, and the device to laser connector (i.e. RFID).

# Intended Use:

Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories that are used with them to deliver laser energy in either CW-pulseTM or LongPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:

532 nm:

Dermatology:

- · Pigmented Skin Lesions
- Vascular Lesions

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, iridoplasty including:

- · Retinal photocoagulation (RPC) for the treatment of
- Diabetic retinopathy, including:
- Nonproliferative retinopathy
- Macular edema

# Premarket Notification Traditional 510(k)

Page 2 of 6

Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories

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- 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

# 577nm

Dermatology:

- · Treatment of Vascular and pigmented lesions
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;
- Choroidal neovascularization:
- Branch retinal vein occlusion;
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

630 - 670nm

Ophthalmology:

Indicated for use in photocoagulation of both anterior and posterior segments including:

Premarket Notification Traditional 510(k) Page 3 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories

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· Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:

- Proliferative and non-proliferative diabetic retinopathy;
- Choroidal neovascularization:
- Branch retinal vein occlusion:
- Age-related macular degeneration
- Retinal tears and detachments
- Retinopathy of prematurity
- · Iridotomy, iridectomy and trabeculoplasty in angle glaucoma and open angle glaucoma

810nm

Ophthalmology:

Indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following examples:

- Retinal photocoagulation for the treatment of:
- Diabetic retinopathy, including:
- . Nonproliferative retinopathy
- Macular edema
- Proliferative retinopathy
- Retinal Tears, Detachments and Holes
- Lattice degeneration
- Age-related macular degeneration (AMD) with choroidal neovascularization (CNV)
- Retinopathy of prematurity
- Sub-retinal (choroidal) neovascularization
- Central and Branch Retinal Vein Occlusion

- Laser trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation (TSCPC) for the treatment of glaucoma, including:

- Primary open angle
- Closed angle
- Refractory Glaucoma (recalcitrant/uncontrolled)

# Technological Characteristics:

Premarket Notification Traditional 510(k) Page 4 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories

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The technological characteristics of the Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532nm], 10 630-670 [630mm-670mm], and 10 810 [810mm]), hand pieces, delivery devices & accessories are substantially equivalent to those of the predicate device. Iridex TruFocus LIO+ Laser Indirect Ophthalmoscope (K071687). See Table 8-1 below.

# Safety and Effectiveness:

The ISO 15004-2 testing proves that the proposed device design meets the accepted design standards for this type of device. Additionally, testing to the following standards IEC60601-2, IEC60601-1, IEC60825-1, IEC60601-2-22, IEC60601-1-6 and IEC62366 prove the safety and effectiveness of this device. A comparison of the technological characteristics proves that technological differences do not raise different questions of safety and effectiveness.

# Conclusion:

The Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532mm], 10 577 [577nm], IQ 630-670 [630nm-670mm], and IQ 810 [810mm]), hand pieces, delivery devices & accessories was found to be substantially equivalent to the predicate device - Iridex TruFocus LIO+ (K071687).

The Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532mm], 10 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810mm]), hand pieces, delivery devices & accessories shares identical indications for use, similar design features, and functional features with the predicate Iridex TruFocus LIO+ and therefore is substantially equivalent.

The Iridex TruFocus LIO Premiere with the Family of Iridex® IO Laser Systems (10 532 [532m], IO 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810mm]), hand pieces, delivery devices & accessories was found to be as safe, as effective and performs as well as or better than the predicate Iridex TruFocus LIO+ Laser Indirect Ophthalmoscope.

Table 8-1: Salient characteristics of the Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (10 532 [532nm], 10 577 [577nm], 10 630-670 [630nm-670nm], and 10 810 [810mm]), hand pieces, delivery devices & accessories and the predicate devices.

| | Iridex TruFocus LIO Premiere with<br>the Family of Iridex® IQ Laser<br>Systems (IQ 532 [532nm], IQ 577<br>[577nm], IQ 630-670 [630nm-<br>670nm], IQ 810 [810nm]), hand<br>pieces, delivery devices & accessories | Iridex TruFocus LIO+ Laser<br>Indirect Ophthalmoscope |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| 510(k) applied and<br>(predicate devices) | New device for which this Traditional<br>510(k) is being submitted | 510(k) number: K071687 |
| Classification<br>Product Code | GEX - Powered Laser Surgical<br>Instrument | GEX - Powered Laser Surgical<br>Instrument |
| Intended Use | Retinal photocoagulation. | Retinal photocoagulation. |
| Type/Design | Indirect Ophthalmoscope Binocular<br>(Headband mounted) | Indirect Ophthalmoscope Binocular<br>(Headband mounted) |
| Treatment<br>Wavelength | 532nm, 577nm, 810nm | 532nm, 577nm, 810nm, 630nm, 670nm |

Premarket Notification Traditional 510(k)

Page 5 of 6

Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories

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| Eye Filter OD | 6 @ 532 nm & 577nm, 2 @ 810 nm | 6 @ 532 nm & 577nm, 2 @ 810 nm |
|---------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Working Distance | 370mm +/- 10mm | 370mm +/- 10mm |
| Fiber Length | 13'8" | 13'8" |
| Aerial Spot Size | Standard LIO spot size: 1.1mm<br>(0.043in) ±10% | Standard LIO spot size: 1.1mm<br>(0.043in) ±10% |
| | Large LIO spot size: 4.0mm (0.157in)<br>±10% | Large LIO spot size: 4.0mm (0.157in)<br>±10% |
| Illumination Source | LED Illumination light source standard<br>with optional Halogen bulb | Halogen Lamp |
| Cooling System | Air Cooled | Air Cooled |
| Electrical | Heine rechargeable battery. Operates<br>on 100-240VAC, 50/50Hz. Optional<br>wall plug in charger. | 6V DC from Iridex Laser console |
| Weight | ≤ 1000gm (2.2 lbs.) with battery<br>installed | 1.2 lbs. |

Premarket Notification Traditional 510(k) Page 6 of 6 Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), hand pieces, delivery devices & accessories