The neoV980 & neoV1470 Diode Lasers, (and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation, and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.

Device Description

neoV980 & neoV1470, members of the neoV Diode Lasers family, cleared under K133006, are medical grade, solid-state, infrared Diode lasers, designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 980nm and 1470nm respectively, with power level ranging from 10 to 20 Watts respectively. The lasers are controlled via a high-resolution color touch screen. The touch screen display includes a user interface allowing selection of continuous, repeat pulse, or single pulse modes of operation as well as repetition rates, aiming beam settings, password key protection, and standby/ready mode selection. The units have an emergency shut off button on the front of the unit.

The Laser System: The laser system consists of an optical block which contains the laser diode, mirrors, lens, and aiming beam diode, an air cooling system, and electronics which include the color touch screen control panel. The unit utilizes an external low voltage power supply, as well as an external wired foot switch for laser activation.

The Delivery System: The delivery system consists of either sterile fibers (not provided with the system) or non-sterile fibers and hand pieces. Safety goggles, non sterile fibers, handpieces and a safety sign are provided with the unit.

AI/ML Overview

The provided document is a 510(k) summary for the neoV980 & neoV1470 Diode Lasers. This document describes a traditional medical device (laser surgical instrument), not an AI/ML-powered device. Therefore, the specific questions regarding acceptance criteria, study details, ground truth, and expert involvement for AI/ML performance assessment are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. The "acceptance criteria" and "study" in this context refer to the testing and analysis performed to support this claim of substantial equivalence for a physical medical device.

Here's an interpretation of the relevant information provided:

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

Since this is not an AI/ML device, performance is demonstrated by compliance with recognized standards and comparison to predicate devices, rather than a specific set of accuracy metrics.

Acceptance Criteria (Demonstrated through compliance with standards and comparison)	Reported Device Performance (Summary of how neoV980 & neoV1470 meet criteria)
Safety: Compliance with medical electrical equipment safety standards.	Passed all tests for IEC 60601-2-22: 2007 (Third Edition), IEC 60601-1: 2005 (Third Edition), IEC 60825-1:2007, and EN 60601-1-2: 2007.
Effectiveness: Similar intended use, technological characteristics, and performance to legally marketed predicate devices.	The neoV980 & neoV1470 Diode Lasers share the same intended use, technical, and performance characteristics of the predicate devices.
Technical Specifications: Energy delivery at specified wavelengths and power levels.	Delivers continuous or pulsed infrared laser energy at wavelengths of 980nm and 1470nm, with power level ranging from 10 to 20 Watts respectively.
Control Features: User interface for selecting modes, settings, and safety features.	Controlled via a high-resolution color touch screen; includes user interface for continuous, repeat pulse, or single pulse modes, repetition rates, aiming beam settings, password key protection, standby/ready mode selection, and an emergency shut-off button.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable for this type of device submission. Performance is assessed through engineering tests and comparison to predicates, not a clinical test set with data provenance.

3. 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. There is no "ground truth" in the AI/ML sense. The evaluation relies on standardized engineering tests and regulatory review by the FDA.

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

Not applicable.

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, as this is not an AI-assisted device.

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

Not applicable.

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

Not applicable. The "truth" for this device is its compliance with international safety and performance standards for medical lasers and its similarity to predicate devices.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

In summary, the provided document details the substantial equivalence of a diode laser system to pre-existing predicate devices, primarily through compliance with established electrical and laser safety standards and by demonstrating similar functional and technical characteristics. It does not involve AI/ML technology, and therefore, the requested information regarding AI/ML specific performance metrics, ground truth, and study designs is not present.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the silhouettes of the human faces.

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

December 8, 2015

G.N.S neoLaser Ltd. Mr. Gil Shapira Chief Executive Officer 7 Ha'Eshel Str. 38900 Caesarea ISRAEL, P.O. Box 3203

Re: K152722 Trade/Device Name: neoV980 & neoV1470 Diode Lasers 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: July 15, 2015 Received: September 21, 2015

Dear Mr. Shapira:

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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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.

Sincerelv vours.

Joshua C. Nipper -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K152722

Device Name neoV980 & neoV1470 Diode Lasers

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Ise (Part 21 CER 801 Subnart D)	Over-The-Counter Use (21 C.FR 801 Subnart C.

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Image: neoLaser logo	neoV FDA 510(k) Submission K152722Section 5 – 510(k) Summary			Revision #2
Ha'Eshel St. 7, 38900, Caesarea ISRAEL	PO Box 3203, Phone:+972 4 677 9919, Fax:+972 4 8591505	SOP Number:DHF-001-R-025-5	EffectiveDate:July 15, 2015	Page 10Section 5

510(k) SUMMARY

Title:	neoV980 & neoV1470 Diode Lasers
Submitter:	G.N.S neoLaser Ltd.Ha'Eshel St. 7, 38900, Caesarea ISRAEL, PO Box 3203
Contact:	Gil Shapira, CEOG.N.S neoLaser Ltd.Ha'Eshel St. 7, 38900, Caesarea ISRAEL, PO Box 3203Phone: +972 52 2246965Fax: +972 4 859 1505Email: shapirag@neo-laser.com
DatePrepared:	July 15, 2015
Device TradeName:	neoV980 & neoV1470 Diode Lasers
CommonName:	Laser surgical instrument for use in general surgery and dermatology
ClassificationName:	Instrument, surgical, powered laserGEX21 CFR 878.4810
PredicateDevices:	Quanta Diode Laser Family (K100558), Ceralas 1470nm Diode Laser(K112253) and Ceralas 980nm Diode Laser (K112324)
Device	Description: neoV980 & neoV1470, members of the neoV Diode Lasers family, clearedunder K133006, are medical grade, solid-state, infrared Diode lasers, designedto deliver continuous or pulsed, infrared laser energy at wavelengths of 980nmand 1470nm respectively, with power level ranging from 10 to 20 Wattsrespectively. The lasers are controlled via a high-resolution color touch screen.The touch screen display includes a user interface allowing selection ofcontinuous, repeat pulse, or single pulse modes of operation as well asrepetition rates, aiming beam settings, password key protection, andstandby/ready mode selection. The units have an emergency shut off button on

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Image: neo Laser logo	neoV980 & neoV1470 Diode Lasers 510(k)Submission510(k) Summary			Revision #2
Ha'Eshel St. 7, 38900, Caesarea ISRAEL	PO Box 3203, Phone:+972 4 677 9919, Fax:+972 4 8591505	SOP Number:DHF-001-R-025-	Effective Date:July 15, 2015	Page 11Section 5

the front of the unit.

Intended

Use:

The neoV980 & neoV1470 Diode lasers are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.

Substantial

Equivalence: The neoV980 & neoV1470 Diode Lasers share the same intended use, technical and performance characteristics of the predicate devices Quanta System QUANTA Diode Laser Family (K100558), the Ceralas 1470nm Diode Laser (K112253) and the Ceralas 980nm Diode Laser (K112324).
Conclusion: From a design and clinical perspective, the predicates and subject laser devices, have the same technological characteristics and share the same intended use. Accordingly, the safety and effectiveness of the neoV980 & neoV1470, is based upon a determination of the substantial equivalence to the predicate devices.

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Image: neo Laser	neoV980 & neoV1470 Diode Lasers 510(k)Submission510(k) Summary		Revision #2
Ha'Eshel St. 7, 38900, Caesarea ISRAEL			Page 12
PO Box 3203, Phone:+972 4 677 9919, Fax:+972 4 8591505	SOP Number:DHF-001-R-025-	EffectiveDate:July 15, 2015	Section 5

Non clinical Performance

Data:

The neoV Diode Laser family including neoV980 & neoV1470 has been tested for compliance to IEC 60601-2-22: 2007 (Third Edition), Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment, IEC 60601-1: 2005 (Third Edition) Medical electrical equipment Part 1: General requirements for basic safety and essential performance and tested for compliance with all functional requirements, IEC 60825-1:2007 Safety of Laser Products - Part 1: Equipment classification, requirements and user's guide, EN 60601-1-2: 2007, Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.

Clinical Performance Data: None

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.