neoV980 & neoV1470 Diode Lasers

K152722 · G.N.S Neolaser , Ltd. · GEX · Dec 8, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K152722
• Device Name: neoV980 & neoV1470 Diode Lasers
• Applicant: G.N.S Neolaser , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

Solid-state infrared diode lasers (980nm and 1470nm) deliver continuous or pulsed energy for soft tissue surgical applications. System comprises optical block (laser diode, mirrors, lens, aiming beam), air cooling, and electronics. Operated via high-resolution color touch screen; allows selection of pulse modes, repetition rates, and aiming beam settings. Includes emergency shut-off, password protection, and external foot switch for activation. Used in clinical/surgical settings by physicians. Delivery via sterile/non-sterile fibers and handpieces. Output energy facilitates tissue vaporization, incision, excision, ablation, cutting, hemostasis, and coagulation. Benefits include precise tissue management and endovenous occlusion for venous reflux.

Clinical Evidence

No clinical data provided. Bench testing only, including compliance with IEC 60601-2-22 (safety of laser equipment), IEC 60601-1 (general safety/performance), IEC 60825-1 (laser product safety), and EN 60601-1-2 (electromagnetic compatibility).

Technological Characteristics

Solid-state infrared diode lasers; wavelengths 980nm and 1470nm; power 10-20 Watts. Air-cooled. Controlled via color touch screen interface. External low voltage power supply. Wired foot switch activation. Compliant with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and EN 60601-1-2.

Indications for Use

Indicated for patients requiring soft tissue surgery (vaporization, excision, ablation, cutting, hemostasis, coagulation) across various medical specialties including urology, dermatology, and orthopedics; specifically indicated for endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.

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)
• Ceralas 1470nm Diode Laser (K112253)
• Ceralas 980nm Diode Laser (K112324)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 [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/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 [phone] or [phone] 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K152722

Device Name neoV980 & neoV1470 Diode Lasers

#### Indications for Use (Describe)

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.

| 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. |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

| Image: neoLaser logo | neoV FDA 510(k) Submission K152722<br>Section 5 – 510(k) Summary | | | Revision #2 |
|----------------------------------------|------------------------------------------------------------------|--------------------------------|-------------------------------------|----------------------|
| Ha'Eshel St. 7, 38900, Caesarea ISRAEL | PO Box 3203, Phone:[phone], Fax:[phone] | SOP Number:<br>DHF-001-R-025-5 | Effective<br>Date:<br>July 15, 2015 | Page 10<br>Section 5 |

# 510(k) SUMMARY

| Title: | neoV980 & neoV1470 Diode Lasers |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | July 15, 2015 |
| Device Trade<br>Name: | neoV980 & neoV1470 Diode Lasers |
| 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), Ceralas 1470nm Diode Laser<br>(K112253) and Ceralas 980nm Diode Laser (K112324) |
| Device | Description: neoV980 & neoV1470, members of the neoV Diode Lasers family, cleared<br>under K133006, are medical grade, solid-state, infrared Diode lasers, designed<br>to deliver continuous or pulsed, infrared laser energy at wavelengths of 980nm<br>and 1470nm respectively, with power level ranging from 10 to 20 Watts<br>respectively. The lasers are controlled via a high-resolution color touch screen.<br>The touch screen display includes a user interface allowing selection of<br>continuous, repeat pulse, or single pulse modes of operation as well as<br>repetition rates, aiming beam settings, password key protection, and<br>standby/ready mode selection. The units have an emergency shut off button on |

{4}------------------------------------------------

| Image: neo Laser logo | neoV980 & neoV1470 Diode Lasers 510(k)<br>Submission<br>510(k) Summary | | | Revision #2 |
|----------------------------------------|------------------------------------------------------------------------|-------------------------------|----------------------------------|----------------------|
| Ha'Eshel St. 7, 38900, Caesarea ISRAEL | PO Box 3203, Phone:[phone], Fax:[phone] | SOP Number:<br>DHF-001-R-025- | Effective Date:<br>July 15, 2015 | Page 11<br>Section 5 |

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.

### 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.

{5}------------------------------------------------

| Image: neo Laser | neoV980 & neoV1470 Diode Lasers 510(k)<br>Submission<br>510(k) Summary | | Revision #2 |
|--------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------|-------------|
| Ha'Eshel St. 7, 38900, Caesarea ISRAEL | | | Page 12 |
| PO Box 3203, Phone:[phone], Fax:[phone] | SOP Number:<br>DHF-001-R-025- | Effective<br>Date:<br>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