The Novus 3000 Laser System is intended for use in the treatment of ocular pathology. The Novus 3000 Laser System is 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, detachments;
retinopathy of prematurity.
Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

Laser Indirect Ophthalmoscope
The Laser Indirect Ophthalmoscope is indicated for the delivery of laser energy in eyes with retinal pathology. The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments and conditions: diabetic retinopathy (panretinal photocoagulation); peripheral neovascularization, retinal breaks, detachments, and tears, lattice degeneration, pneumatic retinopexy reattachment procedures, segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; pediatric retinal repairs (under general anesthesia), delivery of laser energy through small pupils or to eyes with focal lens opacities.

Endophotocoagulation
When used with a Novus 3000 Laser System, the Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe, and Acculite Illuminating EndoOcular Probe) are intended for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization.

The laser delivery function of the Acculite Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe and Acculite Illuminating EndoOcular Probe) is indicated for use in ocular surgery to deliver laser energy to the treatment area selected by the surgeon.

The aspiration function of the Acculite Aspirating EndoOcular Probe is indicated for use when unwanted fluid is present in the eye during ocular surgery, causing refraction or scattering of the laser beam from the intended treatment site.

The illumination function of the Acculite Illuminating EndoOcular Probe is indicated for use during ocular surgery to illuminate the interior of the eye.

Device Description

Lumenis, Inc.'s Novus® 3000 Laser System with the Delivery Devices is an air cooled, diode-pumped, solid state, Nd: YAG Laser System, which produces a wavelength of 532 um of laser light with a treatment beam output ranging from 50 mw to 3.0 W. The main parts of the Novus® 3000 system include the laser console, a footswitch, a remote control and assorted laser accessories.

AI/ML Overview

This 510(k) summary for the Lumenis Novus® 3000 Laser System and Delivery Devices does not include any performance data or a study to demonstrate that the device meets specific acceptance criteria.

The document explicitly states:

"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). No data was submitted for section 807.92 6[(b)(1)(2)(3c)]."

Therefore, I cannot provide the requested information. The submission relies on demonstrating substantial equivalence to predicate devices based on similarities in intended use, indications for use, and technological characteristics, rather than on new performance data for this specific device.

If this were a submission that included a performance study, the requested information would typically be provided as follows:

Hypothetical Example if performance data were submitted:

Here's how the information would be presented if a study was conducted and acceptance criteria were defined, based on a typical medical device submission structure:

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical Example)

Performance Metric	Acceptance Criteria	Reported Device Performance
Laser Output Power Accuracy	Within ±10% of set value	±5% (e.g., for 50 mW to 3.0 W range)
Beam Spot Size Accuracy	Within ±15% of nominal size	±10% (e.g., for various delivery devices)
Pulse Duration Accuracy	Within ±5% of set value	±2% (e.g., for 10 ms to 1000 ms range)
Aiming Beam Co-axiality	Within 0.5 mm relative to treatment beam	<0.2 mm
Thermal Performance (e.g., temperature rise of handpiece)	Below X°C for Y continuous operation	Z°C (well within limits)

2. Sample Size Used for the Test Set and Data Provenance (Hypothetical Example)

Sample Size for Test Set: E.g., 5 units of the Novus® 3000 Laser System and a representative sample of each delivery device (e.g., 10 Laser Indirect Ophthalmoscopes, 15 Endophotocoagulation Probes).
Data Provenance: Prospective, collected at the manufacturer's facility in Santa Clara, CA, USA, under controlled laboratory conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications (Hypothetical Example)

This type of assessment would typically involve engineering and quality control experts rather than clinical experts for ground truth establishment.

Number of Experts: 3-5 Engineers and Quality Control personnel.
Qualifications: E.g., Lead Optical Engineer (15 years experience in laser systems), Senior Electrical Engineer (10 years experience in medical device electronics), Quality Assurance Manager (12 years experience in medical device testing and regulatory compliance).

4. Adjudication Method for the Test Set (Hypothetical Example)

Adjudication Method: For quantitative measurements, results would be recorded by trained technicians/engineers. Any discrepancies or outliers would be investigated and resolved by the lead engineer and QA manager through re-testing or thorough review of methodology. For subjective assessments (e.g., ergonomic evaluation), a consensus approach among the expert panel might be used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical Example)

Given this is a physical laser device, an MRMC study related to interpretation of results or diagnostic performance (like for an imaging AI) is not applicable. The device's direct performance is based on its physical properties and output.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop) (Hypothetical Example)

Again, this term is more relevant for AI/software devices. For a hardware device like a laser, the "standalone performance" is exactly what the hypothetical performance table above would describe – the device's intrinsic operational metrics without a human actively making real-time adjustments for the test. The clinician is always "in the loop" during actual treatment.

7. Type of Ground Truth Used (Hypothetical Example)

Ground Truth: Primarily based on metrology standards and established physical principles. This would involve using calibrated measurement equipment (e.g., power meters, beam profilers, oscilloscopes) traceable to national standards to objectively quantify the laser's output characteristics against its design specifications.

8. Sample Size for the Training Set (Hypothetical Example)

For a hardware device, the concept of a "training set" is usually not applicable in the same way it is for AI/machine learning algorithms. Device design and manufacturing processes are refined through iterative testing and quality control during development. The "training" for such a device comes from engineering principles, material science, and prior models.

9. How the Ground Truth for the Training Set Was Established (Hypothetical Example)

As above, not directly applicable in the AI sense. Ground truth in the development phase would be established through engineering specifications, design verification, and validation testing against intended performance requirements, using calibrated equipment and standard test methods.

Summary

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Ko52526

NOV 1 5 2005

510 (k) Summarv

General Information:

Submitter:

Lumenis, Inc. 2400 Condensa Street Santa Clara, CA 95051

Contact Person: Tel: Fax:

Karen Baker Tel : (408) 764-3603 (408) 764-3934 Fax:

Summary Date of Preparation: September 12, 2005

Names:

Proprietary Name: Common Name: Classification Name: Novus® 3000 Laser System and Delivery Devices Nd: YAG Laser Laser Instrument, Surgical, Powered (21 CFR 878.4810, Product Code 79 GEX)

Predicate Devices:

Novus® Varia (K022181) Novus® Spectra (K022327) LaserLink Zeiss Slit Lamp Delivery Adapters (LaserLink Z and Z-1000) (K022181; K022327, K032357) LaserLink HS Slit Lamp Laser Delivery Adapter (K022327, K032357) Lumenis 1000 Integrated Slit Lamp (K052129) Laser Indirect Ophthalmoscope (Heine and Keeler models) (K022181, K022327, K032357) Lumenis Acculite Endophotocoagulation Probe Delivery System (Acculite Endoprobe/Endokit) (K022181, K022327, K032357) Illuminating EndoOcular Probe (K022357, K931784)

Aspirating EndoOcular Probe (K022357, K931072)

Lumenis's Novus® 3000 Laser System and Delivery Devices is substantially equivalent to the Lumenis Novus® Varia and the Lumenis Novus® Spectra manufactured and distributed by Lumenis, Inc. Salt Lake City, Utah. The Novus® 3000 Ophthalmic Laser System with Delivery Devices and Accessories share the same intended uses, indications for use and the same or similar technological characteristics including: treatment wavelengths, laser active medium, pumping system, aiming beam, mode of operation, exposure duration, power, treatment intervals, spot sizes, controls and displays, laser energy delivery control (foot switch), and delivery systems as the predicate devices identified above.

Device Description

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Kośź, 76

Intended Use:

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, detachments; 1
- retinopathy of prematurity. -
Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and ● open angle glaucoma.

Laser Indirect Ophthalmoscope

The Laser Indirect Ophthalmoscope is indicated for the delivery of laser energy in eves with retinal pathology. The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments and conditions. diabetic retinopathy (panretinal photocoagulation); peripheral neovascularization, retinal breaks, detachments, and tears, lattice degeneration, pneumatic retinopexy reattachment procedures, segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; pediatric retinal repairs (under general anesthesia), delivery of laser energy through small pupils or to eyes with focal lens opacities.

Endophotocoagulation

The Acculite EndoOcular Probe is indicated or use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization.

The illumination function of the Acculite Illuminating EndoOcular Probe is indicated for use during ocular surgery to illuminate the interior of the eye.

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iKos226

Technological Characteristic Similarities

The Novus 3000 Laser System and Delivery Devices is similar in intended use and mode of operation to the Lumenis Novus® Varia and the Lumenis Novus® Spectra. The Novus 3000 Laser System and Delivery Devices, the Novus Varia and the Novus Spectra all utilize a frequency doubled ND: YAG, diode-pumped solid state system. The laser control system. mode of operation, laser actuation, pulse counter, treatment intervals, aiming beam and the exposure times, which are adjustable in variable increments, are the same for the predicate devices as well as the Novus 3000® Laser System. In addition, the same Delivery Systems are available for the predicate devices and the Novus 3000.

Performance Data:

No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). No data was submitted for section 807.92 6[(b)(1)(2)(3c)].

Conclusion:

The Novus® 3000™ with Delivery Devices is substantially equivalent to the Novus Varia Ophthalmic Laser and Delivery Devices and the Novus Spectra Laser with Delivery Devices. The Novus® 3000™ Laser with Delivery Devices share intended use, indications for use, and technological characteristics as the predicate ophthalmic laser systems.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized depiction of a human figure, with three abstract lines representing the head, body, and legs. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the upper half of the circle.

Public Health Service

NOV 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karen Baker Manager, Regulatory Affairs Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051

Re: K052526 Trade/Device Name: Novus 3000 Laser and Delivery Devices Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 12, 2005 Received: September 14, 2005

Dear Ms. Baker:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2- Karen Baker

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbare Buchup

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K052526 510(k) Number (if known):

Novus 3000 Laser and Delivery Devices Device Name:

Indications For Use:

Retinal photocoagulation, panretinal photocoagulation and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy; r
- choroidal neovascularization; -
- branch retinal vein occlusion; -
- age-related macular degeneration; -
- retinal tears, detachments; -
- retinopathy of prematurity. .
Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle . glaucoma.

Laser Indirect Ophthalmoscope

The Laser Indirect Ophthalmoscope is indicated for the delivery of laser energy in eyes with retinal pathology. The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments and conditions: diabetic retinopathy (panretinal photocoagulation); peripheral neovascularization, retinal breaks, detachments, and tears, lattice degeneration, pneumatic retinopexy reattachment procedures, segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; pediatric retinal repairs (under general anesthesia), delivery of laser energy through small pupils or to eyes with focal lens opacities.

Prescription Use X (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 CDRH, Office of Device Evaluation (ODE)

Charbare fruchnd
Division Sign here

and Neurological Devices

510(k) Number K052526

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Indications for Use

510(k) Number (if known):

Device Name: 002126 Novus 3000 Laser and Delivery Devices

Indications For Use, Continued:

Endophotocoagulation

When used with a Novus 3000 Laser System, the Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe, and Acculite Illuminating EndoOcular Probe) are intended for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization.

The illumination function of the Acculite Illuminating EndoOcular Probe is indicated for use during ocular surgery to illuminate the interior of the eye.

Prescription Use __ X (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 CDRH, Office of Device Evaluation (ODE)

barban Buehup

Neurological Devic

5101 Number K052524

Page 2 of 2

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.