The Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope with the Family of Iridex® IQ Laser Systems (IQ 532 [532nm], IQ 577 [577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), 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;
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 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. 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).

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device: the Iridex TruFocus LIO Premiere with the Family of Iridex® IQ Laser Systems. This document is a regulatory submission to the FDA, not a study report designed to prove the device meets acceptance criteria through clinical performance.

The focus of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, primarily by comparing technological characteristics and intended use. The "acceptance criteria" and "study" described in the prompt are typically associated with performance studies for novel devices or significant modifications, often involving clinical trials or rigorous analytical validation. This document does not describe such studies for proving performance in the context of AI/ML, human readers, or image analysis.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, and training data is not present in this 510(k) submission.

However, I can extract the following information which partially relates to your request:

1. Table of acceptance criteria and reported device performance:

The document states that the device's safety and effectiveness are proven by testing to various ISO and IEC standards. These standards implicitly contain acceptance criteria for the electrical, optical, and mechanical safety and performance of the laser system and ophthalmoscope. The "reported device performance" is the statement that the device meets these standards.

Acceptance Criteria Category (Implied by Standards)	Reported Device Performance
Design Standards	ISO 15004-2 met
Electrical Safety	IEC60601-2 met
General Medical Electrical Equipment	IEC60601-1 met
Laser Product Safety	IEC60825-1 met
Diagnostic and Surgical Laser Equipment	IEC60601-2-22 met
Usability Engineering Process	IEC60601-1-6 met
Application of Usability Engineering to Medical Devices	IEC62366 met

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable/not mentioned. This 510(k) submission relies on demonstrating substantial equivalence through a comparison of technological characteristics and adherence to recognized safety standards, not a specific performance study on a "test set" of patient data for AI/ML.
Data Provenance: Not applicable. No patient data or clinical imagery test sets are described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not a study involving expert validation of a diagnostic output. The "ground truth" for this type of device (a laser surgical instrument) is its adherence to engineering and safety specifications and intended function.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set requiring expert adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This device is a laser indirect ophthalmoscope and laser delivery system, not an AI/ML diagnostic or image assistance device. Therefore, no MRMC study or AI assistance is relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device does not feature a standalone algorithm in the sense of AI/ML for diagnosis or image analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's submission is based on engineering specifications, performance standards (e.g., laser power output accuracy, beam stability, optical clarity, electrical safety), and comparison to a legally marketed predicate device. There is no biological or clinical "ground truth" data (like pathology or outcomes) discussed in this substantial equivalence determination beyond the general safety and effectiveness of the device type for its intended use.

8. The sample size for the training set:

Not applicable. This document does not describe the development or validation of an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.

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.

{1}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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;

{3}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{4}------------------------------------------------

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{5}------------------------------------------------

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: 650-605-8807 Fax: 650-962-0486 Email: gdy@iridex.com

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:

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

{6}------------------------------------------------

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

{7}------------------------------------------------

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

{8}------------------------------------------------

· 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

{9}------------------------------------------------

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 withthe Family of Iridex® IQ LaserSystems (IQ 532 [532nm], IQ 577[577nm], IQ 630-670 [630nm-670nm], IQ 810 [810nm]), handpieces, delivery devices & accessories	Iridex TruFocus LIO+ LaserIndirect Ophthalmoscope
510(k) applied and(predicate devices)	New device for which this Traditional510(k) is being submitted	510(k) number: K071687
ClassificationProduct Code	GEX - Powered Laser SurgicalInstrument	GEX - Powered Laser SurgicalInstrument
Intended Use	Retinal photocoagulation.	Retinal photocoagulation.
Type/Design	Indirect Ophthalmoscope Binocular(Headband mounted)	Indirect Ophthalmoscope Binocular(Headband mounted)
TreatmentWavelength	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

{10}------------------------------------------------

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(0.043in) ±10%	Standard LIO spot size: 1.1mm(0.043in) ±10%
	Large LIO spot size: 4.0mm (0.157in)±10%	Large LIO spot size: 4.0mm (0.157in)±10%
Illumination Source	LED Illumination light source standardwith optional Halogen bulb	Halogen Lamp
Cooling System	Air Cooled	Air Cooled
Electrical	Heine rechargeable battery. Operateson 100-240VAC, 50/50Hz. Optionalwall plug in charger.	6V DC from Iridex Laser console
Weight	≤ 1000gm (2.2 lbs.) with batteryinstalled	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

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.