For the posterior segment, the Lumenis® Array™ LaserLink™ device is indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Proliferative and severe and very severe nonproliferative diabetic retinopathy
- Macular edema associated with proliferative or nonproliferative diabetic retinopathy
- Choroidal neovascularization
- Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion; Central retinal vein occlusion)
- Macular edema associated with Branch retinal vein occlusion
- Retinal tears and detachments
And anterior segments as follows:
- Iridotomy in closed angle glaucoma
- Trabeculoplasty in open angle glaucoma

Device Description

The Lumenis® Array™ LaserLink™ device is a delivery system that adapts an examination slit lamp for use as a therapeutic laser delivery system, utilizing a scanning pattern generator to deliver predefined patterns of treatment. The Lumenis® Array™ LaserLink™ device is comprised of the following components:

ArrayTM LaserLink™M module .
. Console
. Touchscreen display
Remote touchpad .

The Array™ LaserLink™ module attaches to the slit lamp and delivers the treatment beam to the target tissue.

The console houses the control electronics and power supply, and integrates the Array™ LaserLinkTM module with the laser system.

The touchscreen display is used to adjust laser treatment settings, such as laser mode, energy, and aiming beam intensity. It can be positioned on either side of the slit lamp, and duplicates the functions of the laser's remote control.

The touchpad is used to micromanipulate the position of the aiming and treatment beams, adjust laser power, spot size, the number of spots, and pattern parameters.

AI/ML Overview

The provided 510(k) summary for the Lumenis® Array™ LaserLink™ describes a medical device, not an AI/ML algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.

Here's the summary of the acceptance criteria and study findings based on the provided text:

Device: Lumenis® Array™ LaserLink™ (an ophthalmic laser delivery system)

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance (as stated in the document)
Safety	Compliance with IEC 60601 Series standards (electrical safety & EMC requirements).	"IEC Testing has been completed and reports received." and "been subjected to outside independent laboratory testing regarding electrical safety & EMC requirements per governing IEC 60601 Series."
Performance	Meet all determined design specifications.	"undergone protocol governed verification & validation to ensure the subject product met all determined design specifications."
Functional Testing	Functionality as intended.	Not explicitly detailed as a separate criterion, but implied by "performance and functional testing" and "met all determined design specifications."
Substantial Equivalence	Demonstrate substantial equivalence to cited predicate devices in intended use, technology, indications for use, principles of operation, method of energy delivery, critical materials, and basal design elements.	"The Lumenis® Array™ LaserLink™ device has equivalent intended use as the identified predicate device...and also employs the same fundamental scientific technology...service similar indications for use, equivalent principles of operation, method of energy delivery, critical materials, and basal design elements when directly compared." and "similar design features, functional characteristics, fundamental technology features, technical applications, service similar indications for use, and general modes of operation are substantially equivalent to cited predicate devices."

No acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, F1 score, AUC, or other typical AI/ML metrics are present, as this is not an AI/ML device.

Study Details (as related to a non-AI/ML medical device)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not applicable as the document describes a hardware medical device and its performance testing, primarily for electrical safety and functional equivalence, not a study involving patient data or a test set in the context of an AI/ML model. The testing mentioned is "side-by-side comparative performance assessment to competitive products" and "verification & validation to ensure the subject product met all determined design specifications," which refers to engineering and design validation, not a clinical study on a patient test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. "Ground truth" in the context of an AI/ML model's performance on a test set is not relevant for this device. The "ground truth" for the device's design specifications would be defined by engineering standards and regulatory requirements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method for a test set is described, as this is not an AI/ML diagnostic or prognostic device.
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:
- Not applicable. This device is a laser delivery system, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device; there is no standalone algorithm. Its function is to deliver laser treatment through a slit lamp.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of AI/ML evaluation. The "ground truth" for this device's performance is adherence to engineering specifications, safety standards (IEC 60601 Series), and functional requirements validated through engineering tests.
The sample size for the training set:
- Not applicable. There is no training set mentioned or implied for this non-AI/ML device.
How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned or implied for this non-AI/ML device.

Summary

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ડ. 510(k) SUMMARY

510(k) Summary

NOV 0 1 2013

I. Submitter General Information:

Device Owner Name:	Lumenis, Inc.
Address:	3959 West 1820 SouthSalt Lake City, UT 84104
Contact:	Jace R. McLane
Phone:	801-656-2328
Fax:	801-656-2415
Date of Preparation:	March 1, 2013
Device Name:
Trade Name:	Lumenis ® ArrayTM LaserLinkTM

Common/Usual Name(s): Surgical Laser Class: Class II Classification Name(s): HQF, Laser, Ophthalmic CFR Reference: 21 CFR § 886.4390, Ophthalmic Laser

III. Predicate Device Name(s):

II.

Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi Trade Name(s): (#K111493). Topcon PASCAL Streamline 577 (#K111108). Topcon (OptiMedica) PASCAL Streamline Photocoagulator (#K100019) Lumenis Vision One Laser System (#K111213)

IV. Device Description:

ArrayTM LaserLink™M module .
. Console
. Touchscreen display
Remote touchpad .

The Array™ LaserLink™ module attaches to the slit lamp and delivers the treatment beam to the target tissue.

The console houses the control electronics and power supply, and integrates the Array™ LaserLinkTM module with the laser system.

T. 801-656-2300 F. 801-656-2415 www.lumenis.com

Image /page/0/Picture/19 description: The image shows the word "LUMENIS" in a stylized font. To the left of the word is a circular graphic with lines inside. The word "LUMENIS" is in all capital letters, and there is a small circle above and to the right of the "S". The image is in black and white.

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The touchpad is used to micromanipulate the position of the aiming and treatment beams, adjust laser power, spot size, the number of spots, and pattern parameters.

V. Intended Use:

Device Name: Lumenis® Array™ LaserLinkTM

Indications for Use:

The Lumenis® Array™ LaserLink™ device is a laser system accessory intended for use in the treatment of ocular pathology.

For the posterior segment, the Lumenis® ArrayTM LaserLink™ . device is indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
- o Proliferative and severe and very severe nonproliferative diabetic retinopathy
- o Macular edema associated with proliferative or nonproliferative diabetic retinopathy
- o Choroidal neovascularization
- o Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion; Central retinal vein occlusion)
- o Macular edema associated with Branch retinal vein occlusion
- o Retinal tears and detachments
And anterior segments as follows: .
- o Iridotomy in closed angle glaucoma
- o Trabeculoplasty in open angle glaucoma

The Lumenis Laser Systems compatible for connection with the Lumenis® Array™ LaserLink™ device are:

Novus Spectra™ Laser System (K022327)(532nm) .
Novus Spectra™ Dual Port Laser System (K022327)(532nm) .
. Vision One™ Laser System (K111213)(532nm, 577nm, 659nm)

Table 2 Pattern Indications For Use

Condition	Treatment	PatternSelectionOption	SpecificPattern
Posterior segment: Retina
Proliferative Diabetic Retinopathy	Panretinal Photocoagulation	Yes	All patternsexcept circle/halfcircle arc

LUMENIS®

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K130195

Severe and Very Severe Non-Proliferative Diabetic Retinopathy	Panretinal Photocoagulation	Yes	All patternsexcept circle/halfcircle arc
Macular Edema associated withProliferative or Non-Proliferative	Focal Photocoagulation	No	Single Spot (nopattern)
Diabetic Retinopathy	Grid Photocoagulation	Yes	Square, arc, line
Retinal neovascularization associated Panretinal Photocoagulationwith Retinal Occlusive Disease(Branch Retinal Vein Occlusion;Central Retinal Vein Occlusion)		Yes	All patternsexcept circle/halfcircle arc
Macular Edema associated withBranch Retinal Vein Occlusion	Grid Photocoagulation	Yes	Square, arc, line
Retinal Tears and Detachments	aser Retinopexy	Yes	Circle, halfcircle, quartercircle
Choroidal Neovascularization	Focal Laser	No	Single Spot (nopattern)
Anterior Segment: Glaucoma
Primary Open-Angle Glaucoma	Trabeculoplasty	No	Single Spot (nopattern )
Closed Angle Glaucoma	Iridotomy	No	Single Spot (nopattern)

VI. Substantial Equivalence Summary:

The Lumenis® Array™ LaserLink™ device has equivalent intended use as the identified predicate device - Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi (#K111493), Topcon PASCAL Streamline 577 (#K111108), Topcon (OptiMedica) PASCAL Streamline Photocoagulator (#K100019); and Lumenis Vision One Laser System (#K111213), and also employs the same fundamental scientific technology as the identified predicate devices. In addition, the subject device, Lumenis® Array™ LaserLink™, and the predicate devices service similar indications for use, equivalent principles of operation, method of energy delivery, critical materials, and basal design elements when directly compared.

			Table 2 510(k) Summary Predicate Comparison
--	--	--	---------------------------------------------

	PredicateDevice	PredicateDevice	Predicate Device	Predicate Device	Subject Device
Charact-eristics	K111493Nidek MC-500Vixi	K111108TopconPASCALStreamline577	K100019Topcon/OptiMedicaPASCALStreamlinePhotocoagulator	K111213Lumenis VisionOne LaserSystem	K130195Lumenis®Array™LaserLink™
Treatment λ	532nm, 577nm,& 647nm	577nm	532nm	532nm, 577nm,659nm	532nm, 577nm, &659nm

Lumenis, Inc. 3959 West 1820 South Salt Lake City, Utah 84104

T. 801-656-2300 F.801−656−2415 www.lumenis.com

Image /page/2/Picture/8 description: The image shows the word "LUMENIS" in a stylized font. The first two letters, "LU", are combined into a single symbol that resembles a circle with a vertical line through it. The rest of the letters are spaced out evenly and are in a bold, sans-serif font. There is a small circle above and to the right of the "S".

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	PredicateDevice	PredicateDevice	PredicateDevice	Predicate Device	Subject Device
Charact-eristics	K111493Nidek MC-500Vixi	K111108TopconPASCALStreamline577	K100019Topcon/OptiMedicaPASCALStreamlinePhotocoagulator	K111213Lumenis VisionOne LaserSystem	K130195Lumenis®Array™LaserLink™
Laser Type	Diode PumpedSolid State	OPSL -OpticallyPumped Semi-conductorLaser	OPSL - OpticallyPumped Semi-conductor Laser	OPSL -OpticallyPumped Semi-conductor Laser	OPSL - OpticallyPumped Semi-conductor Laser
Power Input	100-240 VAC	100-240 VAC	100-240 VAC	100-240 VAC	100-240 VAC
Display Type& Userinterface	Color LCDpanel w /Touchscreen	AdjustableLCDtouchscreencontrol panel(color)	Adjustable LCDtouchscreen controlpanel (color)	Color LCD panelw / Touchscreen	Color LCD panelw / Touchscreen
CompatibleLasers	Integrated:Nidek MC-500: 532nm,577nm, 647nm(Integrated)	Integrated:TopconPASCALStreamline577: 577nm(Integrated)	Integrated:Topcon /OptiMedicaPASCALStreamlinePhotocoagu-lator:532nm(Integrated)	Laser with Green(532nm), Yellow(577nm), & Red(659nm)wavelengthSingle spotdelivery.	Non-Integrated:Lumenis VisionOne: 532nm,577nm, 659nmLumenis NovusSpectra Family:532nm

VII. Performance Data:

The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted for the subject Lumenis® Array™ LaserLink™ device. IEC Testing has been completed and reports received. The Test Reports use the colloquial name of Scanning LaserLink™ rather than the determined trade name of Array™ LaserLinkTM.

The subject Array™ LaserLink™ product has been subjected to outside independent laboratory testing regarding electrical safety & EMC requirements per governing IEC 60601 Series, been subjected to side-by-side comparative performance assessment to competitive products, and has undergone protocol governed verification & validation to ensure the subject product met all determined design specifications and was substantially equivalent to named predicates. As a result, Lumenis verifies that all established testing criteria and product performance specifications have been duly met, demonstrating that equivalent indications for use, safety compliance, similar design features, functional characteristics, fundamental technology features, technical applications, service similar indications for use, and general modes of operation are substantially equivalent to cited predicate devices.

Lumenis, Inc. 3959 West 1820 South Salt Lake City. Utah 84104

T. 801-656-2300 F. 801-656-2415 www.lumenis.com

Image /page/3/Picture/7 description: The image shows the logo for Lumenis. The logo consists of a stylized letter 'L' in a circle, followed by the word 'LUMENIS' in all capital letters. A small circle is present above and to the right of the 'S' in 'LUMENIS'.

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Based on the indications for use, technological characteristics, and safety and performance testing, the subject Array™ LaserLink™ product meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, technical features, service of similar indications for use, principles of operation and indications for use to current commercially available scanners/cited predicates.

VIII. Conclusion:

The Lumenis® Array™ LaserLink™ subject device has equivalent intended use, general design, and fundamental scientific technology as the predicate devices -Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi (#K111493), Topcon PASCAL Streamline 577 (#K111108), Topcon (OptiMedica) PASCAL Streamline Photocoagulator (#K100019), and Lumenis Vision One Laser System (#K111213). There are no new hazards introduced by the Lumenis® Array™ LaserLink™M device as compared with the predicate devices.

Lumenis, Inc. 3959 West 1820 South Salt Lake City, Utah 84104 T. 801-656-2300 F. 801-656-2415 www.lumenis.com

Image /page/4/Picture/6 description: The image shows the word "LUMENIS" in a stylized font. The first letter, "L", is part of a circular design to the left of the word. There is a small superscript symbol to the right of the "S" in "LUMENIS".

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread.

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

November 1, 2013

Lumenis, Incorporated Mr. Jace R. McLane Regulatory Affairs Specialist 3959 West 1820 South Salt Lake City, Utah 84194

Re: K130195

Trade/Device Name: Lumenis® Array" LaserLink" Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HOF Dated: October 4, 2013 Received: October 10, 2013

Dear Mr. McLane:

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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Jace R. McLane

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Mark N Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K130195

Device Name: Lumenis® Array™ LaserLink ™

The Lumenis® Array™ LaserLink™ device is a laser system accessory intended for use in the treatment of ocular pathology.

For the posterior segment, the Lumenis® Array™ LaserLink™ device is . indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
o Proliferative and severe and very severe nonproliferative diabetic retinopathy

o Macular edema associated with proliferative or nonproliferative diabetic retinopathy

o Choroidal neovascularization
o Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion: Central retinal vein occlusion)

o Macular edema associated with Branch retinal vein occlusion o Retinal tears and detachments

And anterior segments as follows: .
- o Iridotomy in closed angle glaucoma
- o Trabeculoplasty in open angle glaucoma

The Lumenis Laser Systems compatible for connection with the Lumenis® Array™ LaserLink™ device are:

. Novus Spectra™ Laser System (K022327)(532nm)
Novus Spectra™ Dual Port Laser System (K022327)(532nm) .
Vision One™ Laser System (K111213)(532nm, 577nm, 659nm) .

Page 1 of 3

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Condition	Treatment	PatternSelectionOption	SpecificPattern
Posterior segment: Retina
Proliferative DiabeticRetinopathy	Panretinal Photocoagulation	Yes	All patternsexceptcircle/halfcircle arc
Severe and Very Severe Non-Proliferative DiabeticRetinopathy	Panretinal Photocoagulation	Yes	All patternsexceptcircle/halfcircle arc
Macular Edema associatedwith Proliferative or Non-Proliferative DiabeticRetinopathy	Focal Photocoagulation	No	Single Spot(no pattern)
Macular Edema associatedwith Proliferative or Non-Proliferative DiabeticRetinopathy	Grid Photocoagulation	Yes	Square, arc,line
Retinal neovascularizationassociated with RetinalOcclusive Disease (BranchRetinal Vein Occlusion;Central Retinal VeinOcclusion)	Panretinal Photocoagulation	Yes	All patternsexceptcircle/halfcircle arc
Macular Edema associatedwith Branch Retinal VeinOcclusion	Grid Photocoagulation	Yes	Square, arc,line
Retinal Tears andDetachments	Laser Retinopexy	Yes	Circle, halfcircle, quartercircle
Choroidal Neovascularization	Focal Laser	No	Single Spot(no pattern)
Anterior Segment: Glaucoma
Primary Open-AngleGlaucoma	Trabeculoplasty	No	Single Spot(no pattern)
Closed Angle Glaucoma	Iridotomy	No	Single Spot(no pattern)

Table 1 Pattern Indications For Use

Page 2 of __3

・

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Prescription Use __XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Neil R Ogden
2013.11.01 16:14:43 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130195_______________________________________________________________________________________________________________________________________________________

Page 3 of ___ 3_

Regulation Number and Section

§ 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.