The Lumenis® Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows:

Ophthalmology
Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy Proliferative Diabetic Retinopathy (PDR) Retinal Tear Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO) Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) Central Serous Chorioretinopathy (CSCR) Trabeculoplasty for Primary Open Angle Glaucoma (POAG) Iridotomy / Iridoplasty for Angle-Closure Glaucoma (ACG)

Ear, Nose and Throat (ENT) Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic procedures

Dermatology Pigmented lesion, including soar lentigine Vascular lesions, including cherry hemangiomas and angiokeratomas Extremeties telangiectases, including facial and leg telangiectases Cutaneous lesions Flat warts Dermatosis Papulosa Nigra

Dentistry Frenectomy Treatment of oral mucous cyst Treatment of benign vascular lesions: Capillary hemangioma Hemorrhagic hereditary telangiectasia Capillary/cavernous hemangiomas Lymphangioma AV malformation of the tongue Hermaniolymphangiomas Photocoagulation of superficial vessels Vaporization of superficial blood or lymph containing vessels Treatment of superficial tongue lesions Tissue management and hemostasis for crown and bridge impressions Incision and drainage for abscess Gingivoplasty/Gingivectomy: Operative procedures Crown and bridge, gingival reduction Crown lengthening Hyperplasia (Drug, irritation, Epulus, ... ) Hemostasis during dental procedures Operculectomy (Operculotomy) Excisional biopsy Free Ginvical Graft (Adjunct): Hemostasis of donor site Hemostasis of graft site Vestibuloplasty Soften Gutta Percha Treatment of canker sores, herpetic lesions, and aphthous ulcers Laser-assisted bleaching/whitening

Device Description

The subject Lumenis® Smart532™ Laser System product is a dual port, solid state, frequency doubled, green Nd:GdVO4 surgical laser instrument used in the photothermolysis (photocoagulation) of soft tissue at an operating emission wavelength of 532nm, a wavelength that has been used widely and effectively in the market for procedures in the fields of ophthalmology, ENT (ear, nose & throat), dermatology and dentistry.

Compatible delivery devices & accessories for use with the subject Lumenis® Smart532™ Laser System include: Slit lamps, Slit lamp adapters/attachments, Laser Indirect Ophthalmoscopes (LIO), Eye safety filters, Laser links, Array LaserLink, Selecta Trio, Fibers and Endo-ocular and Endo-Oto probes. The device software may be adjusted by Lumenis to fit customer needs within the system overall range of parameters.

AI/ML Overview

This document is a 510(k) summary for the Lumenis® Smart532™ Laser System, seeking clearance from the FDA. It declares substantial equivalence to predicate devices, focusing on technical specifications rather than clinical study results demonstrating diagnostic or treatment accuracy. Therefore, information regarding acceptance criteria, study sample sizes (for test and training sets), expert consensus, ground truth establishment, MRMC studies, or standalone algorithm performance, which are typical for AI/ML device submissions, is not present in this document.

The document discusses performance data in a general sense, referring to engineering performance testing (electrical safety, EMC requirements, functional testing) to ensure the device meets design specifications and is substantially equivalent to predicates. It does not refer to clinical performance in terms of diagnostic effectiveness or AI accuracy metrics.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implicit): The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has "equivalent indications for use, safety compliance, similar design features, functional characteristics, fundamental technology features, technical applications, patient population, and general modes of operation."
Reported Device Performance:
- The document states that "Appropriate testing for the subject Smart532™ Laser System device, including safety, performance and functional testing, has been performed to determine substantial equivalence..."
- Specifically, "electrical safety & EMC requirements per governing IEC 60601 3"-Edition Series, and side-by-side comparative performance assessment to the identified primary predicate Lumenis® Novus Spectra™ Laser System (K022327)" were performed.
- It concludes that "all established testing criteria and product performance specifications have been met."
- The "Device Comparison Table" on page 7 implicitly serves as a performance comparison, showing that key characteristics (wavelength, aiming beam, laser type, power input/output, operating mode, pulse duration, pulse/exposure interval) are either identical or similar with explanations for differences (e.g., SmartPulse vs. MicroPulse). However, this table does not present "acceptance criteria" in the traditional sense of numerical thresholds for clinical accuracy (e.g., sensitivity, specificity). It's a technical comparison for substantial equivalence.

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

Not Applicable / Not Provided: This type of information (patient sample sizes for a test set) is typically relevant for studies validating diagnostic or predictive AI/ML algorithms. This submission is for a surgical laser system, and the "performance data" refers to engineering and functional testing, not clinical data from patient populations in the context of an AI test set. There's no mention of a "test set" in this context.

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

Not Applicable / Not Provided: As in point 2, this is relevant for AI/ML validation. Ground truth for a surgical laser system's performance would relate to its physical outputs (power, pulse duration, wavelength) and safety features, measured by instruments and engineering standards, not expert readers.

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

Not Applicable / Not Provided: This is a method for resolving discrepancies in expert labeling of ground truth data, relevant for AI/ML studies.

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:

Not Applicable / Not Provided: This document does not describe an AI-assisted device. It describes a surgical laser. Therefore, MRMC studies are not relevant to this submission.

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

Not Applicable / Not Provided: This pertains to AI/ML software. The device is a physical laser system.

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

Implicit (Engineering Standards): The "ground truth" for this device's performance would be established through engineering measurements against industry standards (e.g., IEC 60601 for electrical safety and EMC) and comparison to the technical specifications of the predicate devices. It's not based on clinical outcomes or expert consensus on medical images.

8. The sample size for the training set:

Not Applicable / Not Provided: This is for AI/ML models.

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

Not Applicable / Not Provided: This is for AI/ML models.

In summary, this document is a 510(k) premarket notification for a physical medical device (a surgical laser system), not an AI/ML diagnostic or therapeutic device. The "acceptance criteria" and "study" described are focused on demonstrating technical substantial equivalence to predicate devices and adherence to engineering safety and performance standards, rather than clinical performance metrics typically associated with AI/ML validation studies.

Summary

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

October 30, 2015

Lumenis Incorporated Mr. Rick Gaykowski Global Vice President, Regulatory Affairs & Quality Systems 1870 South Milestone Drive Salt Lake City, Utah 84101

Re: K151109 Trade/Device Name: Lumenis® Smart532™ Laser System and 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: August 20, 2015 Received: August 27, 2015

Dear Mr. Gaykowski:

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 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice

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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" (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 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,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S.

For 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 (if known) K151109

Device Name

Lumenis® Smart532TM Laser System and accessories

Indications for Use (Describe)

The Lumenis® Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows:

Ophthalmology

Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy Proliferative Diabetic Retinopathy (PDR) Retinal Tear Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO) Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) Central Serous Chorioretinopathy (CSCR) Trabeculoplasty for Primary Open Angle Glaucoma (POAG) Iridotomy / Iridoplasty for Angle-Closure Glaucoma (ACG)

Ear, Nose and Throat (ENT) 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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Vaporization of superficial blood or lymph containing vessels Treatment of superficial tongue lesions Tissue management and hemostasis for crown and bridge impressions Incision and drainage for abscess Gingivoplasty/Gingivectomy: Operative procedures Crown and bridge, gingival reduction Crown lengthening Hyperplasia (Drug, irritation, Epulus, ... ) Hemostasis during dental procedures Operculectomy (Operculotomy) Excisional biopsy Free Ginvical Graft (Adjunct): Hemostasis of donor site Hemostasis of graft site Vestibuloplasty Soften Gutta Percha Treatment of canker sores, herpetic lesions, and aphthous ulcers Laser-assisted bleaching/whitening

Device energy delivery options:

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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Lumenis Smart532™ Laser System 510(K) Summary

I. Submitter General Information:

Device Owner Name:	Lumenis, Inc.
Address:	1870 S Milestone DrSalt Lake City, UT 84104
Contact:	Jace R. McLane
Phone:	801-656-2328
Fax:	801-656-2415
Date of Preparation:	18 September, 2015
Device Name:
Trade Name:	Lumenis® Smart532™ Laser System
Common/Usual Name(s):	Surgical Laser
Class:	Class II
Classification Name(s):	79 GEX, Laser Instrument, Surgical Powered
CFR Reference:	21 CFR § 878.4810, Laser surgical instrument for use ingeneral and plastic surgery and in dermatology

III. Predicate Device Name(s):

Trade Name(s):	Lumenis® Novus Spectra™ Laser System (K022327)Iridex® IQ 532 Laser System (K071687)
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IV. Device Description:

II.

V. Intended Use:

The subject Lumenis® Smart532™ Laser System delivery device is indicated for a variety of uses, identical to unaltered indications from the primary predicate Lumenis® Novus Spectra™ Laser System (K022327), to direct indications enumerated within the product Operator Manual, as follows:

The Lumenis Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows:

Image /page/4/Picture/13 description: The image shows the logo for Lumenis, a medical device company. The logo consists of a stylized letter "L" in blue, followed by the company name "LUMENIS" in a matching blue font. The logo is simple and modern, and the blue color gives it a professional and trustworthy look. The registered trademark symbol is present to the right of the company name.

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Ophthalmology

Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy Proliferative Diabetic Retinopathy (PDR) Retinal Tear Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO). Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) Central Serous Chorioretinopathy (CSCR) Trabeculoplasty for Primary Open Angle Glaucoma (POAG)

Iridotomy / Iridoplasty for Angle-Closure Glaucoma (ACG)

Ear, Nose and Throat (ENT)

Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic procedures

Dermatology

Pigmented lesion, including soar lentigine Vascular lesions, including cherry hemangiomas and angiokeratomas Extremeties telangiectases, including facial and leg telangiectases Cutaneous lesions Flat warts Dermatosis Papulosa Nigra

Dentistry

Frenectomy Treatment of oral mucous cyst Treatment of benign vascular lesions

Capillary hemangioma
Hemorrhagic hereditary telangiectasia ●
Capillary/cavernous hemangiomas ●
Lymphangioma
AV malformation of the tongue ●
Hemangiolymphangiomas .

Photocoagulation of superficial vessels Vaporization of superficial blood or lymph containing vessels Treatment of superficial tongue lesions Tissue management and hemostasis for crown and bridge impressions Incision and drainage for abscess Gingivoplasty/Gingivectomy

Operative procedures
Crown and bridge, gingival reduction ●
. Crown lengthening

Hyperplasia (Drug, irritation, Epulus ... )

Image /page/5/Picture/22 description: The image shows the word "LUMENIS" in blue font. The "L" in LUMENIS is stylized with a blue circle and a vertical line. The word "LUMENIS" is written in all capital letters. There is a registered trademark symbol next to the word "LUMENIS".

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Hemostasis during dental procedures Operculectomy (Operculotomy) Excisional biopsy Free Ginvical Graft (Adjunct):

Hemostasis of donor site
Hemostasis of graft site

Vestibuloplasty

Soften Gutta Percha

Treatment of canker sores, herpetic lesions, and aphthous ulcers Laser-assisted bleaching/whitening

Device energy delivery options

Energy Delivery Option	Indication
SmartPulse	Diabetic Retinopathy including MacularEdema or Proliferative Retinopathy,Proliferative Diabetic Retinopathy(PDR), Central Serous Chorioretinopathy(CSCR), Macular Edema or ProliferativeRetinopathy associated with BranchRetinal Vein Occlusion (BRVO)
CW (Continuous Wave)	All Indications

VI. Substantial Equivalence Discussion:

The subject Lumenis® Smart532™ and primary predicate Lumenis® Novus Spectra™ Laser System (K022327) are based on a diode pumped solid state frequency doubled laser.

Both subject and predicate(s) devices' laser systems (Lumenis® Novus Spectra Laser System (K022327) and Iridex® IQ 532 Laser System (K071687)) share the same 532 nm output, a wavelength that has been used widely and effectively in the market for procedures in the fields of ophthalmology, ENT (ear, nose & throat), dermatology and dentistry. The Iridex IQ 532 Laser System (K071687) is not cleared for any dentistry indications. The outputs of both systems' laser sources also share the same power range characteristics.

Additional design changes such as dual port, addition of touch screen etc., did not raise new questions of safety and effectiveness and did not alter the basic fundamental scientific technology of the device.

The subject device, Lumenis® Smart532 Laser System and primary predicate Lumenis® Novus Spectra Laser System (K022327) do not share the SmartPulse (train of brief pulses) energy delivery method. However, the Iridex® IQ 532 Laser System secondary predicate (K071687) does include a MicroPulse (spaced, single and repetitive train of brief pulses) energy delivery method, which is similar in terms of temporal ranges to the SmartPulse of the subject device and establishes substantial equivalence as shown in the table below:

Image /page/6/Picture/15 description: The image shows the word "LUMENIS" in a sans-serif font. The word is in blue, and the "L" is stylized with a curved shape. The word "LUMENIS" is followed by the registered trademark symbol.

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Characteristics	Subject Device -Lumenis® Smart532™Laser System	Primary PredicateDevice - Lumenis®Novus Spectra™ LaserSystem (K022327)	Secondary PredicateDevice – Iridex® IQ532 Laser System(K071687)
Indications forUse	Ophthalmic, ENT,Dermatology, &Dentistry	Ophthalmic, ENT,Dermatology, &Dentistry (SeeK022327)	Dermatology,ENT/otolaryngology, &Ophthalmic (SeeK071687)
Treatmentwavelength	532nm	532nm	532nm
Aiming beam	Diode, 635nm	Diode, 635nm	Diode, 635nm
Laser Type	Diode Pumped SolidState (frequencydoubled)	Diode Pumped SolidState (frequencydoubled)	Diode, Diode-pumped,frequency doubled,solid state
Power Input	100-240 VAC	100-240 VAC	100-240 VAC
Power Output	50-2,500mW (nominal)	50-1,500mW	0-2,500mW
Operating mode	Single Pulse, CW(Continuous Wave),SmartPulse	Single Pulse, CW(Continuous Wave)	CW(CW-Pulse,MicroPulse, LongPulse
Pulse duration	Single Pulse CW: 5 -3,000msecSmartPulse: 0.05-1.00msec	Single Pulse, CW: 10-3,000msec	CW: 10-3,000msecMicroPulse: 0.05-1.00msec
Pulse/Exposureinterval	CW: 10-1,500msecSmartPulse: 0.5-10msec	CW: 50-1,000msec	CW: 10-3,000msecMicroPulse: 1.00 -10.00msec
Display Typeand UserInterface	Color display panelw/Touchscreen &pushbutton selectors	Monochromatic sevensegment indicators andpushbutton selectors	Color GraphicTouchscreenmanual/RemoteControls

Table 1: 510(k) Summary Device Comparison Table

VII. Performance Data:

Appropriate testing for the subject Smart532™ Laser System device, including safety, performance and functional testing, has been performed to determine substantial equivalence to the predicate devices Lumenis® Novus Spectra™ Laser System and Iridex® IQ 532 Laser System .

The subject Lumenis® Smart532™ Laser System product has been subjected to outside independent laboratory testing regarding electrical safety & EMC requirements per governing

Image /page/7/Picture/7 description: The image shows the logo for Lumenis, a medical device company. The logo consists of a stylized letter "L" in blue, followed by the company name "LUMENIS" in blue sans-serif font. A small registration mark is present to the right of the name.

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IEC 60601 3"-Edition Series, and side-by-side comparative performance assessment to the identified primary predicate Lumenis® Novus Spectra™ Laser System (K022327). The subject product has undergone verification & validation protocol controlled examination testing to ensure the subject product met all determined design specifications and was determined as substantially equivalent. As a result. Lumenis maintains that all established testing criteria and product performance specifications have been met, demonstrating that equivalent indications for use, safety compliance, similar design features, functional characteristics, fundamental technology features, technical applications, patient population, and general modes of operation of the subject device are indeed substantially equivalent to cited predicate devices.

Based on the indications for use, technological characteristics, safety and performance testing, the subject Lumenis® Smart532™ Laser System product meets the requirements considered adequate for its intended use and is substantially equivalent in design, materials, technical features, treatment population, principles of operation and indications for use to current commercially available cited predicates.

VIII. Conclusion:

The Lumenis® Smart532™ Laser System subject device has equivalent intended use, general design, and fundamental scientific technology as the predicate devices: Lumenis® Novus Spectra™ Laser System (K022327) and the Iridex® IQ 532 Laser System (K071687). There are no new hazards introduced by the Lumenis® Smart532™ Laser System subject device as compared with the cited predicate devices.

Image /page/8/Picture/6 description: The image shows the logo for Lumenis. The logo is blue and features the company name in a sans-serif font. The logo has a stylized "L" on the left side of the word.

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.