NEOV DIODE LASER FAMILY

K133006 · G.N.S Neolaser , Ltd. · GEX · Apr 17, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133006
• Device Name: NEOV DIODE LASER FAMILY
• Applicant: G.N.S Neolaser , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The neoV810 diode laser is 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 specialist 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. The neoV980 diode laser is 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 specialist 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. The neoV1064 diode laser is 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 specialist 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. The neoV1470 diode laser is 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 specialist 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.

Device Story

Solid-state infrared diode laser system; delivers continuous or pulsed laser energy at 810nm, 980nm, 1064nm, or 1470nm wavelengths. System comprises optical block (laser diode, mirrors, lens, aiming beam), air cooling, and electronics. Operated via high-resolution color touch screen; allows selection of mode (continuous, repeat pulse, single pulse), repetition rates, and aiming beam settings. Includes emergency shut-off button and external foot switch for activation. Used in clinical/surgical settings by medical specialists. Laser energy delivered via fiber optics and handpiece to target soft tissue. Provides precise tissue interaction for surgical procedures; benefits include controlled cutting and hemostasis.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and compliance with international safety standards (IEC 60601-1, IEC 60601-2-22, IEC 60825-1, EN 60601-1-2).

Technological Characteristics

Solid-state infrared diode laser; wavelengths 810, 980, 1064, 1470nm; power 8-20W. Fiber optic delivery; green 532nm aiming beam. Color touch screen interface. Power: 100-240V, 47-63Hz. Dimensions: 22x22x10cm; weight 3.5kg. Air-cooled. Standards: IEC 60601-1 (safety), IEC 60601-2-22 (laser safety), IEC 60825-1 (laser classification), EN 60601-1-2 (EMC).

Indications for Use

Indicated for soft tissue surgical applications (vaporization, incision, excision, ablation, cutting, hemostasis, coagulation) in conjunction with endoscopic equipment across various medical specialties including Urology, Thoracic, Plastic, Dermatology, General, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal, Gynecology, Pulmonary, Neurosurgery, Gastroenterology, ENT, and Dental/Oral surgery.

Regulatory Classification

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.

Predicate Devices

• Quanta Diode Laser Family (K100558)
• Sheaumann Laser PL-1064 (K120938)

Submission Summary (Full Text)

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neoV FDA 510(k) Submission

Section 5 – 510(k) Summary

| Ha'Eshel St. 7, 38900, Caesarea ISRAEL | Revision #2 |
|----------------------------------------|-------------|
|----------------------------------------|-------------|

| SOP Number: | DHF-001-R-014-5 | Effective Date: | 15.3.14 | Page 10 |
|--------------------------------------------------------|-----------------|-----------------|---------|---------|
| PO Box 3203, Phone:[phone], Fax:[phone] | | Section 5 | | |

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# 510k SUMMARY

K133006

APR 1 7 2014

| Title: | neoV Diode Laser Family |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | G.N.S neoLaser Ltd.<br>Ha'Eshel St. 7, 38900, Caesarea ISRAEL, PO Box 3203 |
| Contact: | Gil Shapira, CEO<br>G.N.S neoLaser Ltd.<br>Ha'Eshel St. 7, 38900, Caesarea ISRAEL, PO Box 3203<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date<br>Prepared: | August 29, 2013 |
| Device Trade<br>Name: | neoV Diode Laser Family |
| Common<br>Name: | Laser surgical instrument for use in general surgery and dermatology |
| Classification<br>Name: | Instrument, surgical, powered laser<br>GEX<br>21 CFR 878.4810 |
| Predicate<br>Devices: | Quanta Diode Laser Family (K100558)<br>Sheaumann Laser PL-1064 (K120938) |
| Device<br>Description: | The neo V Diode Laser Family are medical grade, solid-state, infrared diode<br>lasers. They include 5 models - neoV810, neoV980, neoV1064 (LSV1064-10<br>and LSV1064-20), and neoV1470, and are designed to deliver continuous or<br>pulsed, infrared laser energy at wavelengths of 810nm, 980nm, 1064nm, and<br>1470mm respectively, at power levels ranging from 8Watts up to 20Watts. The<br>lasers are controlled via a high-resolution color touch screen. The touch screen<br>display includes a user interface allowing selection of continuous, repeat pulse,<br>or single pulse modes of operation as well as repetition rates, aiming beam<br>settings, password key protection, and standby/ready mode selection. The units<br>have an emergency shut off button on the front of the unit. |

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| Image: neoLaser logo | neoV FDA 510(k) Submission<br>Section 5 – 510(k) Summary | Revision #2 | | |
|--------------------------------------------------------|----------------------------------------------------------|--------------------------------|-------------------------------|-----------|
| Ha'Eshel St. 7, 38900, Caesarea ISRAEL | | SOP Number:<br>DHF-001-R-014-5 | Effective<br>Date:<br>15.3.14 | Page 11 |
| PO Box 3203, Phone:[phone], Fax:[phone] | | | | Section 5 |

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 fiber optics and a hand piece. Safety goggles and a safety sign are also provided with the unit.

## Intended Use:

The neoV810 diode laser is 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 specialist 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.

The neoV980 diode laser is 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 specialist 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.

The neoV1064 diode laser is 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 specialist 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.

The neoV1470 diode laser is 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 specialist 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.

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| Image: neoLaser logo | neoV FDA 510(k) Submission<br>Section 5 – 510(k) Summary | | | Revision #2 |
|----------------------|----------------------------------------------------------|-----------------|--------------------|-------------|
| | Ha'Eshel St. 7, 38900, Caesarea ISRAEL | SOP Number: | Effective<br>Date: | Page 12 |
| | PO Box 3203, Phone:[phone], Fax:[phone] | DHF-001-R-014-5 | 15.3.14 | Section 5 |

Comparison: The neoV Diode Laser Family share the same technical and performance characteristics of the Quanta System OUANTA Diode Laser Family, and the Sheaumann PL-1064 systemn. Below is a table summarizing the comparison of the devices:

| Specification | neoV Diode Laser Family | QUANTA Diode Laser Family | Sheaumann Laser PL-1064 |
|---------------------|---------------------------------------------------------|-----------------------------------|---------------------------------------------------------|
| Ref 510(k) | K133006 | K100558 | K120938 |
| Wavelength [nm] | 810, 980, 1064, 1470 | 808, 980, 1064, 1470 | 1064 |
| Max Power [W] | 8 - 810nm | 30 - 808nm | 10 - 1064nm |
| | 20 - 980nm | 30 - 980nm | |
| | 10 - 1064nm (LSV1064-10) | 30 - 1064nm | |
| | 20 - 1064nm (LSV1064-20) | 15 - 1470nm | |
| | 10 - 1470nm | | |
| Laser media | Diode | Diode | Diode |
| Output mode | CW, Pulsed, Single Pulse | CW, Pulsed, Single Pulse | CW, Pulsed, Single Pulse |
| Spot Size | 0.7mm, 1mm, 1.5mm | 0.6mm, 0.8mm, 1.2mm, 1.8mm, 2.4mm | 0.7mm, 1.5mm, 3mm, 5mm, 7mm |
| Pulse Duration | 100 $ \mu $ sec - 30 sec adjustable | 3 msec - 2.5 sec adjustable | 200 $ \mu $ sec - 30 sec adjustable |
| Aiming Beam | Green 532nm (<5mW) | Red 650nm (<5mW) | Red 635-650nm (<1mW) |
| Power Source | 100 - 240 V, 47-63 Hz | 100-240V, 50-60Hz | 100-240V, 47-63Hz |
| User Interface | Color touch screen | Color touch screen | LCD touch screen |
| Laser Beam Delivery | Fiber | Fiber | Fiber |
| Dimensions [cm] and | 22(L) X22(W) X10(H) | 39(L) X33(W)X25(H) | 22 X 25 X 12 |
| Weight [Kg] | 3.5Kg | 8Kg | 3Kg |

Summary: From a design and clinical perspective, the predicates and candidate laser devices, have the same technological characteristics and share the same intended use. Accordingly, the safety and effectiveness of the neoV Diode Laser Family is based upon a determination of the substantial equivalence to the predicate devices.

# Non clinical

Performance

Data:

The neo V Diode Laser family 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.

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| neoLaser | neoV FDA 510(k) Submission<br>Section 5 – 510(k) Summary | | | Revision #2 |
|--------------------------------------------------------|----------------------------------------------------------|--------------------------------|-------------------------------|-------------|
| Ha'Eshel St. 7, 38900, Caesarea ISRAEL | | SOP Number:<br>DHF-001-R-014-5 | Effective<br>Date:<br>15.3.14 | Page 13 |
| PO Box 3203, Phone:[phone], Fax:[phone] | | | | Section 5 |

Clinical
Performance None Data:

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 17, 2014

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

Re: K133006

Trade/Device Name: neo Diode Laser Family 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 16, 2014 Received: March 25, 2014

# 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 that I Dr mas intacted and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Gil Shapira

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 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 [phone] or [phone] 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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on fast page.

#### 510/k) Number (if known) K133006

#### Device Name

#### neoV Diode Laser Family

#### Indications for Use (Describe)

The neo V810 diode laser is indical for use in surgications requiring the vaporization, incision, ablation, cutting and hemosasis, or coagulation of soft tissue in conjunction with endescopic equipment for medical specialist including: Unlogy, Thoracic Surgery, Plastic Surgery and Dermatology, Central Surgery, Ophthalmology, Orthopedics, Podiatry, Arthrosopy, Spinal Surgery, Gyzecology, Pulmonary Surgery, Gastrocaterology, Headinedogy, Oral Surgery, Oral Surgery and Denal procedures.

The neoV980 diode laser is indications requiring the vaporization, incision, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Unlogy, Thoracic Surgery, Plastic Surgery and Dermatology, Central Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Gstroenterology, HeadineskENT and Radiology, Oral Sugery and Dental procedures.

The no V 1064 diode laser is in surgical applications requiring the vaporization, incision, ablation, coding and hemostasis, or coagulation of soft tissue in conjunction with endical specialist including: Unlogy, Thoracic Surgery, Plastic Surgery and Dermatology, Ophthalmology, Orthopedics, Podiaty, Arthrosopy, Spinal Surgery, Gyneology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Headined/ENT and Radiology, Oral Surgery and Dental procedures.

The neoV1470 diode laser is indicated for use in surgical application, incision, incision, excision, abisting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Artirosopy, Spiral Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Headneck/BNT and Radiology, Oral Surgery and Dental, procedures.

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)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FOR USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Neil R Ogden -S 2014.04.16 11:46:28 -04'00'

FORM FDA 3881 (1/14)

**PSC Publishing Services [phone]**

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