(204 days)
Not Found
No
The description focuses on the hardware components and basic control modes of a laser system, with no mention of AI or ML capabilities.
Yes
The device is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, which are procedures aimed at treating medical conditions. Also, the non-clinical performance data references compliance to "Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment".
No
The device is indicated for surgical applications requiring vaporization, incision, excision, ablation, cutting, and hemostasis or coagulation of soft tissue, which are therapeutic functions, not diagnostic.
No
The device description clearly outlines hardware components including a laser diode, mirrors, lens, aiming beam diode, air cooling system, electronics, touch screen control panel, external power supply, external foot switch, fiber optics, and a hand piece. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The neo V Diode Laser Family is described as a surgical laser used for procedures directly on soft tissue within the body (vaporization, incision, excision, etc.). It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states surgical applications on soft tissue.
- Device Description: The description focuses on the laser's components and how it delivers energy for surgical purposes.
- Performance Studies: The performance studies mentioned are related to safety and functional requirements for medical electrical equipment and laser safety, not the analytical performance of an IVD.
Therefore, the neo V Diode Laser Family is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GEX
Device Description
The neo V Diode Laser Family are medical grade, solid-state, infrared diode lasers. They include 5 models - neoV810, neoV980, neoV1064 (LSV1064-10 and LSV1064-20), and neoV1470, and are designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 810nm, 980nm, 1064nm, and 1470mm respectively, at power levels ranging from 8Watts up to 20Watts. 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 fiber optics and a hand piece. Safety goggles and a safety sign are also provided with the unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:+972 4 677 9919, Fax:+972 4 8591505 | Section 5 |
な
『
510k SUMMARY
APR 1 7 2014
| Title: | neoV Diode Laser Family |
|---|---|
| Submitter: | G.N.S neoLaser Ltd. |
| Ha'Eshel St. 7, 38900, Caesarea ISRAEL, PO Box 3203 | |
| Contact: | Gil Shapira, CEO |
| G.N.S neoLaser Ltd. | |
| Ha'Eshel St. 7, 38900, Caesarea ISRAEL, PO Box 3203 | |
| Phone: +972 52 2246965 | |
| Fax: +972 4 859 1505 | |
| Email: shapirag@neo-laser.com | |
| Date | |
| Prepared: | August 29, 2013 |
| Device Trade | |
| Name: | neoV Diode Laser Family |
| Common | |
| Name: | Laser surgical instrument for use in general surgery and dermatology |
| Classification | |
| Name: | Instrument, surgical, powered laser |
| GEX | |
| 21 CFR 878.4810 | |
| Predicate | |
| Devices: | Quanta Diode Laser Family (K100558) |
| Sheaumann Laser PL-1064 (K120938) | |
| Device | |
| Description: | The neo V Diode Laser Family are medical grade, solid-state, infrared diode |
| lasers. They include 5 models - neoV810, neoV980, neoV1064 (LSV1064-10 | |
| and LSV1064-20), and neoV1470, and are designed to deliver continuous or | |
| pulsed, infrared laser energy at wavelengths of 810nm, 980nm, 1064nm, and | |
| 1470mm respectively, at power levels ranging from 8Watts up to 20Watts. 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. |
1
| Image: neoLaser logo | neoV FDA 510(k) Submission
Section 5 – 510(k) Summary | Revision #2 | | |
|--------------------------------------------------------|----------------------------------------------------------|--------------------------------|-------------------------------|-----------|
| Ha'Eshel St. 7, 38900, Caesarea ISRAEL | | SOP Number:
DHF-001-R-014-5 | Effective
Date:
15.3.14 | Page 11 |
| PO Box 3203, Phone:+972 4 677 9919, Fax:+972 4 8591505 | | | | 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.
2
| Image: neoLaser logo | neoV FDA 510(k) Submission
Section 5 – 510(k) Summary | | | Revision #2 |
|----------------------|----------------------------------------------------------|-----------------|--------------------|-------------|
| | Ha'Eshel St. 7, 38900, Caesarea ISRAEL | SOP Number: | Effective
Date: | Page 12 |
| | PO Box 3203, Phone:+972 4 677 9919, Fax:+972 4 8591505 | 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 ( |