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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the neoLaser Laser Surgery Fibers. It describes a medical device and its substantial equivalence to a predicate device, BeaMed Laser Surgery Fibers (K232769). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch.

Therefore, the document does not outline acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device performance study. Instead, it focuses on demonstrating equivalence through comparison of technical characteristics and performance bench testing.

Here's why the requested information cannot be extracted from this document:

The device is a physical medical instrument (laser surgery fibers), not an AI/algorithm-based device. The questions about MRMC studies, human reader improvement with AI, standalone algorithm performance, and ground truth establishment for training/test sets are relevant to AI/ML medical devices, not simple surgical tools.
The 510(k) pathway for this device is based on "substantial equivalence" to a predicate device. This means the manufacturer proves the new device is as safe and effective as an already cleared device through comparison of specifications, materials, and bench testing, not through new clinical performance studies against defined acceptance criteria for a novel technology.
The document explicitly states: "Animal or clinical studies: None." This confirms that performance studies in the way you've outlined for AI/ML models (with test sets, ground truth, expert readers, etc.) were not conducted or required for this 510(k) submission.

However, I can extract information regarding the device's characteristics and the types of "performance" assessments that were deemed sufficient for this 510(k) clearance, even though they don't align with the typical AI/ML study framework you've described.

Based on the provided document, here's an attempt to address the prompt's points, reinterpreting them for a physical medical device clearance based on substantial equivalence:

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

The "acceptance criteria" for a 510(k) submission for a physical device like this are primarily demonstrated through substantially equivalent technical specifications and material properties to a predicate device, along with successful bench testing to ensure safety and functionality. The document presents a comparative table rather than an acceptance criteria table.

Specification	Subject Device (neoLaser Laser Surgery Fibers)	Predicate Device (BeaMed Laser Surgery Fibers)	"Performance" / Outcome (Demonstrated Equivalence)
Indications for Use	General surgical applications (incision, vaporization, ablation, hemostasis, coagulation of soft tissue, endoscopic applications, etc.). Wavelength: 450nm-2100nm. Contact/non-contact mode. Used in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT, endovenous occlusion, laser assisted lipolysis. SMA 905 connector.	Identical wording for Indications for Use.	Met: Substantially equivalent indications for use.
Fiber core material	Silica quartz glass	Silica quartz glass	Met: Identical material.
Fiber cladding material	silica quartz glass cladding and/or Hardclad	silica quartz glass cladding and/or Hardclad	Met: Identical material.
Buffer	silicone buffer	silicone buffer	Met: Identical material.
Jacket material	silicone / ETFE /polymide /nylon / acrylate / PVDF/ PU (with color additives)	silicone / ETFE /polymide /nylon / acrylate / PVDF/ PU (with color additives)	Met: Identical materials.
Maximal temperature	Nylon jacket: 176°F (80°C); ETFE jacket: 302°F (150°C)	Nylon jacket: 176°F (80°C); ETFE jacket: 302°F (150°C)	Met: Identical temperature tolerances.
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)	Met: Identical bend radius specifications.
Maximal laser power	Suitable for laser power up to 100W	Suitable for laser power up to 100W	Met: Identical power handling.
Shelf life	5 years	5 years	Met: Identical shelf life.
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)	Met: Identical numerical aperture range.
Core diameter range	200 µm to 1000 µm	200 µm to 1000 µm	Met: Identical core diameter range.
Outer diameter range	240 µm to 1800 µm typically	240 µm to 1800 µm typically	Met: Identical outer diameter range.
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	Met: Identical tip configurations.
Fiber tip outer diameter range	1.0mm to 1.8mm	1.0mm to 1.8mm	Met: Identical tip diameter range.
Length range	6.5 feet (2 meters) to 9.9 feet (3 meters)	6.5 feet (2 meters) to 9.9 feet (3 meters)	Met: Identical length range.
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°	Met: Identical emission patterns.
Single/multiple use	Single use	Single use	Met: Identical use designation.
Sterility	Sterile by EO	Sterile by EO	Met: Identical sterilization method.
Packaging	Sterile, double pouched	Sterile, double pouched	Met: Identical packaging.
Proximal end	SMA 905 connector	SMA 905 connector	Met: Identical connector type.

Performance Bench Testing included in the submission (serving as "proof"):

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

The success of these tests (implicitly, meeting pre-defined thresholds for each) serves as the "reported device performance" that proves the device's safety and functionality for a 510(k) submission based on substantial equivalence.

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

Not applicable. This is for a physical device, and the submission explicitly states "Animal or clinical studies: None." The "tests" mentioned are bench tests on the device itself or its packaging/materials, not performance studies with human data. Therefore, concepts like sample size for a test set of patient data or data provenance (country, retrospective/prospective) are not relevant here.

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. No "ground truth" was established in the context of an AI/ML algorithm's performance against human expert interpretations or pathology. The evaluation is based on engineering and material specifications, and physical bench testing results.

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

Not applicable. There was no test set requiring expert adjudication.

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. This device is not an AI/ML algorithm that assists human readers.

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

Not applicable. This device is not an AI/ML algorithm.

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

Not applicable. The "ground truth" for this device's clearance is its conformity to engineering specifications, material standards, and successful completion of bench tests (e.g., sterilization efficacy, biocompatibility).

8. The sample size for the training set

Not applicable. There is no AI/ML training set for this physical device.

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

Not applicable. There is no AI/ML training set or associated ground truth.

Summary

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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"

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(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).

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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

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Indications for Use

510(k) Number (if known) K250113

Device Name neoLaser Laser Surgery Fibers

Indications for Use (Describe)

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:

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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 DeviceneoLaser Laser Surgery Fibers	Predicate DeviceBeaMed Laser Surgery Fibers
510(k)	Pending	K232769
Indications forUse	The Fibers are indicated for use ingeneral surgical applications forincision, excision, vaporization,ablation, hemostasis or coagulationof soft tissue. It is also indicated foruse in open or closed endoscopicapplications where incision,excision,tissue dissection, excision ofexternal tumors and lesions, completeor partial resection of internal organs,tumors or lesions, tissuevaporization, hemostasis and orcoagulation may be indicated.The neoLaser Laser Surgery Fibershave a wavelength range of 450 nmto 2100 nm, can be used in contactand non-contact mode and areindicated for use in general surgery,urology, gastroenterology,gynecology, dermatology, vascularsurgery, neurosurgery, plasticsurgery, ENT and endovenousocclusion of the greater saphenous	The Fibers are indicated for usein general surgical applicationsfor incision, excision,vaporization, ablation,hemostasis or coagulation of softtissue. It is also indicated for usein open or closed endoscopicapplications where incision,excision,tissue dissection,excision of external tumors andlesions, complete or partialresection of internal organs,tumors or lesions, tissuevaporization, hemostasis and orcoagulation may be indicated.The BeaMed Laser SurgeryFibers have a wavelength rangeof 450 nm to 2100 nm, can beused in contact and non-contactmode and are indicated for use ingeneral surgery, urology,gastroenterology, gynecology,
	vein in the patient with superficialvein reflux and laser assistedlipolysis with a clearedcompatible laser marketed for thementioned intended uses and usingan SMA 905 connector.	dermatology, vascular surgery,neurosurgery, plastic surgery,ENT and endovenous occlusionof the greater saphenous vein inthe patient with superficial veinreflux and laser assisted lipolysiswith a cleared compatible lasermarketed for the mentionedintended uses and using an SMA905 connector.
Fiber corematerial	Silica quartz glass	Silica quartz glass
Fiber claddingmaterial	silica quartz glass cladding and/orHardclad(depending on type of fiber)	silica quartz glass claddingand/or Hardclad(depending on type of fiber)
Buffer	silicone buffer (depending on type offiber)	silicone buffer (depending ontype of fiber)
Jacket material	silicone / ETFE /polymide /nylon /acrylate / PVDF/ PU may be usedin the jacket depending on type offiber.Color additives (see Biocompatibilitytests) may be included according tofibers models and variants.	silicone / ETFE /polymide/nylon / acrylate / PVDF/ PUmay be used in the jacketdepending on type of fiber.Color additives (seeBiocompatibility tests) may beincluded according to fibersmodels and variants.
Maximaltemperature	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 bendradius	51 x core diameter (short term) 121 xcore diameter (long term)	51 x core diameter (short term)121 x core diameter (long term)
Maximal laserpower	Suitable for laser power up to 100W	Suitable for laser power up to100W
Shelf life	5 years	5 years
Numericalaperture range	0.37 (for quartz/ hardclad fibers),0.22 (for quartz /quartz)	0.37 (for quartz/ hardclad fibers),0.22 (for quartz /quartz)
Core diameterrange	200 µm to 1000 µm	200 µm to 1000 µm
Outer diameterrange	240 µm to 1800 µm typically	240 µm to 1800 µm typically
Distal fiber tiptypes	Flat, conical, ball, spherical orbended bare fibers, round or conicalcaps	Flat, conical, ball, spherical orbended bare fibers, round orconical caps
Fiber tip outerdiameter range	1.0mm to 1.8mm	1.0mm to 1.8mm
Specification	Subject DeviceneoLaser Laser SurgeryFibers	Predicate DeviceBeaMed Laser SurgeryFibers
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

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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

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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

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.