(56 days)
Not Found
No
The 510(k) summary describes laser surgery fibers, which are passive devices for delivering laser energy. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on physical and biological properties of the fibers.
Yes
The device is a medical device intended for surgical applications such as incision, vaporization, ablation, hemostasis, and coagulation, all of which are considered therapeutic interventions.
No
The device description and intended use clearly state that these fibers are for surgical applications involving tissue modification (e.g., incision, vaporization, hemostasis) and energy delivery for treatment, not for diagnosis.
No
The device is described as "sterile, single use, laser delivery devices" and mentions physical components like "fibers" and "SMA 905 connector," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on soft tissue (incision, vaporization, ablation, hemostasis, coagulation, etc.). These are direct interventions on the patient's body.
- Device Description: The device description reinforces this by stating it's a "laser delivery device intended for medical applications in various fields of laser surgery" and delivers energy to "soft tissue."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples for diagnostic purposes. This device is used in vivo (inside or on the body) for surgical treatment.
N/A
Intended Use / Indications for Use
The Fibers are indicated for use in general surgical applications for incision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. The neoLaser Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact mode and are indicated for use in general surgery, urology, gastroenterology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The neoLaser Laser Surgery Fibers are sterile, single use, laser delivery devices intended for medical applications in various fields of laser surgery. They are intended to deliver energy to soft tissue in contact and non-contact mode during various surgical applications, including via endoscopes and cytoscopes. The fibers are designed to transmit energy from the laser system to the treatment site, as well as to transmit a low power laser aiming beam to assist in the visibilty of the target tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, internal organs, tumors, lesions, greater saphenous vein
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Summary of performance bench testing included in the submission:
Packaging seal strength
Dye penetration test
Packaging microbial barrier
Shelf-life validation summary
Sterilization process validation plan
Sterilization process validation protocol
Sterilization process validation report
Sterility Assurance Level (SAL)
EO-ECH residuals report
LAL Endotoxin test
Bioburden bare fibers test / Bioburden capped fibers tests
Biocompatibility tests protocols & reports
Thermal safety validation
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.
BeaMed Laser Surgery Fibers (K232769)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 13, 2025
G.N.S neoLaser Ltd. Gil Shapira CEO Ha'Eshel St. 7 Caesarea, 3088900 Israel
Re: K250113
Trade/Device Name: neoLaser Laser Surgery Fibers 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: January 8, 2025 Received: January 16, 2025
Dear Gil 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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Image /page/2/Picture/3 description: The image shows a digital signature. The name "YAN FU" is prominently displayed on the left side of the image. To the right of the name, the text "Digitally signed by YAN FU" is present, along with the date and time "2025.03.13 17:18:32 -04'00'." The signature indicates that the document has been digitally signed by YAN FU on March 13, 2025, at 5:18:32 PM with a time zone offset of -04'00'.
for Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K250113
Device Name neoLaser Laser Surgery Fibers
Indications for Use (Describe)
The Fibers are indicated for use in general surgical applications for incision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. The neoLaser Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact mode and are indicated for use in general surgery, urology, gastroenterology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image is a square with a black background. In the lower left corner, the word "neolaser" is written in white font. There is a green line that runs underneath the word "neolaser".
7 HaEshel St., Caesarea 3088900, ISRAEL | Tel: +972 4 6779919 | Fax: +972 4 8591505 info@neo-laser.com | www.neo-laser.com
K250113 - neoLaser Laser Surgery Fibers - Traditional Submission - 510(k) Summary
Submitter: G.N.S neoLaser Ltd. (neoLaser) 7 HaEshel St. Caesarea 3088900 Israel Contact person: Gil Shapira, CEO +972 4 6779919 Phone: Fax : + 972 4 8591505 shapirag@neo-laser.com e-Mail: Type of 510(k) Traditional Date January 8, 2025 Prepared: Device Trade Name: neoLaser Laser Surgery Fibers Common Name: Fiber optic laser delivery system Classification Name: General and Plastic Surgery Device product code: GEX Device Classification: 21 CFR 878.4810 Predicate: BeaMed Laser Surgery Fibers (K232769)
Device Description:
The neoLaser Laser Surgery Fibers are sterile, single use, laser delivery devices intended for medical applications in various fields of laser surgery. They are intended to deliver energy to soft tissue in contact and non-contact mode during various surgical applications, including via endoscopes and cytoscopes. The fibers are designed to transmit energy from the laser system to the treatment site, as well as to transmit a low power laser aiming beam to assist in the visibilty of the target tissue.
5
Image /page/5/Picture/0 description: The image is a square logo with rounded corners. The background is black, and the words "neo laser" are written in a sans-serif font. The word "neo" is in a lime green color, and the word "laser" is in white. There is a thin lime green line separating the two words.
7 HaEshel St., Caesarea 3088900, ISRAEL | Tel: +972 4 6779919 | Fax: +972 4 8591505 info@neo-laser.com | www.neo-laser.com
Indications for Use:
The Fibers are indicated for use in general surgical applications for incision, excision. vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
The neoLaser Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
| Specification | Subject Device
neoLaser Laser Surgery Fibers | Predicate Device
BeaMed Laser Surgery Fibers |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Pending | K232769 |
| Indications for
Use | The Fibers are indicated for use in
general surgical applications for
incision, excision, vaporization,
ablation, hemostasis or coagulation
of soft tissue. It is also indicated for
use in open or closed endoscopic
applications where incision,
excision,tissue dissection, excision of
external tumors and lesions, complete
or partial resection of internal organs,
tumors or lesions, tissue
vaporization, hemostasis and or
coagulation may be indicated.
The neoLaser Laser Surgery Fibers
have a wavelength range of 450 nm
to 2100 nm, can be used in contact
and non-contact mode and are
indicated for use in general surgery,
urology, gastroenterology,
gynecology, dermatology, vascular
surgery, neurosurgery, plastic
surgery, ENT and endovenous
occlusion of the greater saphenous | The Fibers are indicated for use
in general surgical applications
for incision, excision,
vaporization, ablation,
hemostasis or coagulation of soft
tissue. It is also indicated for use
in open or closed endoscopic
applications where incision,
excision,tissue dissection,
excision of external tumors and
lesions, complete or partial
resection of internal organs,
tumors or lesions, tissue
vaporization, hemostasis and or
coagulation may be indicated.
The BeaMed Laser Surgery
Fibers have a wavelength range
of 450 nm to 2100 nm, can be
used in contact and non-contact
mode and are indicated for use in
general surgery, urology,
gastroenterology, gynecology, |
| | vein in the patient with superficial
vein reflux and laser assisted
lipolysis with a cleared
compatible laser marketed for the
mentioned intended uses and using
an SMA 905 connector. | dermatology, vascular surgery,
neurosurgery, plastic surgery,
ENT and endovenous occlusion
of the greater saphenous vein in
the patient with superficial vein
reflux and laser assisted lipolysis
with a cleared compatible laser
marketed for the mentioned
intended uses and using an SMA
905 connector. |
| Fiber core
material | Silica quartz glass | Silica quartz glass |
| Fiber cladding
material | silica quartz glass cladding and/or
Hardclad
(depending on type of fiber) | silica quartz glass cladding
and/or Hardclad
(depending on type of fiber) |
| Buffer | silicone buffer (depending on type of
fiber) | silicone buffer (depending on
type of fiber) |
| Jacket material | silicone / ETFE /polymide /nylon /
acrylate / PVDF/ PU may be used
in the jacket depending on type of
fiber.
Color additives (see Biocompatibility
tests) may be included according to
fibers models and variants. | silicone / ETFE /polymide
/nylon / acrylate / PVDF/ PU
may be used in the jacket
depending on type of fiber.
Color additives (see
Biocompatibility tests) may be
included according to fibers
models and variants. |
| Maximal
temperature | 176°F (80°C) for nylon jacket, 302°F
(150°C) for ETFE jacket | 176°F (80°C) for nylon jacket,
302°F (150°C ) for ETFE jacket |
| Minimal bend
radius | 51 x core diameter (short term) 121 x
core diameter (long term) | 51 x core diameter (short term)
121 x core diameter (long term) |
| Maximal laser
power | Suitable for laser power up to 100W | Suitable for laser power up to
100W |
| Shelf life | 5 years | 5 years |
| Numerical
aperture range | 0.37 (for quartz/ hardclad fibers),
0.22 (for quartz /quartz) | 0.37 (for quartz/ hardclad fibers),
0.22 (for quartz /quartz) |
| Core diameter
range | 200 µm to 1000 µm | 200 µm to 1000 µm |
| Outer diameter
range | 240 µm to 1800 µm typically | 240 µm to 1800 µm typically |
| Distal fiber tip
types | Flat, conical, ball, spherical or
bended bare fibers, round or conical
caps | Flat, conical, ball, spherical or
bended bare fibers, round or
conical caps |
| Fiber tip outer
diameter range | 1.0mm to 1.8mm | 1.0mm to 1.8mm |
| Specification | Subject Device
neoLaser Laser Surgery
Fibers | Predicate Device
BeaMed Laser Surgery
Fibers |
| Wavelength range | 450nm to 2100 nm | 450nm to 2100 nm |
| Length range | 6.5 feet (2 meters) to 9.9 feet (3 meters) | 6.5 feet (2 meters) to 9.9 feet (3 meters) |
| Emission angle range | Straight, forward directed cone or 60° cone angle from fiber axis, diffuse emission, and radial 360° | Straight, forward directed cone or 60° cone angle from fiber axis, diffuse emission, and radial emission of 360° |
| Single/multiple use | Single use | Single use |
| Sterility | Sterile by EO | Sterile by EO |
| Packaging | Sterile, double pouched | Sterile, double pouched |
| Proximal end | SMA 905 connector | SMA 905 connector |
Comparison between subiect and predicate devices
6
Image /page/6/Picture/0 description: The image is a logo for a company called "neolaser". The logo is set against a black background. The word "neolaser" is written in a sans-serif font, with the "neo" part in green and the "laser" part in white. A thin green line is placed underneath the word "neolaser".
7 HaEshel St., Caesarea 3088900, ISRAEL | Tel: +972 4 6779919 | Fax: +972 4 8591505
info@neo-laser.com | www.neo-laser.com | www.neo-laser.com
7
Image /page/7/Picture/0 description: The image is a logo for a company called "neo laser". The logo is set against a black background. The words "neo" and "laser" are written in a sans-serif font, with "neo" stacked on top of "laser". A thin green line is placed horizontally below the company name.
7 HaEshel St., Caesarea 3088900, ISRAEL | Tel: +972 4 6779919 | Fax: +972 4 8591505 info@neo-laser.com | www.neo-laser.com
Summary of performance bench testing included in the submission:
Packaging seal strength Dye penetration test Packaging microbial barrier Shelf-life validation summary Sterilization process validation plan Sterilization process validation protocol Sterilization process validation report Sterility Assurance Level (SAL) EO-ECH residuals report LAL Endotoxin test Bioburden bare fibers test / Bioburden capped fibers tests Biocompatibility tests protocols & reports Thermal safety validation
Substantial Equivalence summary and conclusion
The neoLaser Laser Surgery Fibers and the predicate device, the BeaMed Laser Surgery Fibers (K232769) share the same indications for use, the same technical and performance characteristics, accordingly, the safety and effectiveness of the neoLaser Laser Surgery Fibers is based upon a determination of the substantial equivalence to the predicate device.
Conclusion and substantial equivalence statement
After our analysis we have concluded that the subject device neoLaser Laser Surgery Fibers, and the predicate device the BeaMed Laser Surgery Fibers, share the same technical characteristics and the same intended use.
Accordingly, we believe that the neoLaser Laser Surgery Fibers and the legally marketed predicate, the BeaMed Laser Surgery Fibers (K232769), are substantially equivalent. Animal or clinical studies: None