FOX 810:
Indicated for surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, and pulmonology.

FOX 980:
Indicated for surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, pulmonology, and thoracic surgery.

Device Description

The FOX Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode, the laser system can radiate one factory set wavelength with either 810nm or 980mm. The FOX is a compact diode laser with a high-resolution color touchscreen for user control.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the FOX 810 and FOX 980 Diode Laser Systems. It establishes substantial equivalence to predicate devices for surgical applications involving soft tissue. There is no information regarding AI/ML in this document. Therefore, I will answer the questions based on the provided text, primarily focusing on general device performance criteria where applicable.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device (e.g., incision depth, coagulation time) that were then "reported" as meeting those criteria. Instead, it details that the device has been tested against various IEC and EN standards to ensure safety and essential performance, and it performs comparably to its predicate devices in terms of power output and tissue interaction mechanisms.

Performance Characteristic	Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance
Device Safety	Compliance with recognized international standards for medical electrical equipment, laser safety, electromagnetic compatibility, usability, and software lifecycle processes to ensure basic safety and essential performance. (IEC 60601-1, IEC 60825-1, EN 60601-1-2, IEC 60601-2-22, IEC 60601-1-6, IEC 62304)	The FOX systems have been tested against IEC 60601-1:2005+ COR1:2006, COR2:2007, AMD1:2012; IEC 60825-1:2014; EN 60601-1-2:2014; IEC 60601-2-22:2007+A1:2012; IEC 60601-1-6:2010/AMD1:2013; and IEC 62304:2006 + A1:2015. The submission concludes that the new devices are "as safe and effective as the predicate devices."
Tissue Interaction	Similar wavelengths (810nm and 980nm) and power outputs to the predicate devices, ensuring comparable tissue interactions (ablation, vaporization, hemostasis, coagulation) based on absorption in corresponding chromophores. The predicate devices' performance in terms of incision depth and thermal tissue damage sets the implicit benchmark for acceptable tissue interaction.	The device under evaluation uses 810nm and 980nm wavelengths, sharing the same wavelengths as the primary predicates. The power outputs are: FOX 810: Up to 8 W, FOX 980: Up to 12 W. This is compared to primary predicate Fox Q-810 (Up to 7W) and Fox Q-980 (Up to 9W), and secondary predicate XPulse Pro (810nm: Up to 8W, 980nm: Up to 12W). The document states that the power difference "does not absolutely affect the extent of incision depth and thermal tissue damage" and that "Power alone or pulse length alone do not alter the tissue effect because for every pulse the power is set with a pulse length. These parameters, power and pulse length, equal the pulse energy when multiplied." The submission concludes that the subject devices are substantially equivalent to the predicate devices in terms of safety and efficacy.
Operational Modes	Capability for continuous wave, pulsed, and single pulse operation, along with comparable pulse length/duration and frequency ranges to predicate devices.	The subject device operates in Continuous wave, pulsed, single pulse mode. Pulse length/duration: 100μs – 45s. Pulse frequency: 0.01 – 5000 Hz. These are comparable to the predicate devices which have similar modes, and ranges of 2ms - 30s for pulse length/duration and 0.016 – 250 Hz for pulse frequency (primary predicate) or 100 μs to 60 s for pulse length/duration and 0.008 Hz to 5000 Hz for pulse frequency (secondary predicate).
Physical and Functional Characteristics	Similar design, user interface (touchscreen/buttons), aiming beam specifications, cooling method (air), delivery devices (optical fibers), main power supply, dimensions, and weight to predicate devices, ensuring equivalent functionality and usability.	The subject device features a touchscreen and buttons for user interface, air cooling, 532nm or 650nm @ <1mW aiming beam, and uses 300μm, 400μm and 600μm optical fibers. These are consistent with or an improvement upon the predicate devices' specifications, which had either a display with a rotary knob or a touch screen control, similar aiming beam wavelengths/power, air cooling, and similar fiber sizes. Dimensions and weight are also comparable.

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

The document makes no mention of a "test set" in the context of clinical or observational data. The device's performance was evaluated through bench testing against recognized standards and by comparison to predicate device specifications. Therefore, there is no sample size of patients/cases or data provenance information.

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. As there was no clinical "test set" or data analysis requiring ground truth establishment by experts, this information is not provided. The substantial equivalence relies on technical specifications and performance against industry standards rather than expert consensus on clinical outcomes.

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

Not applicable. No clinical test set requiring adjudication was used.

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 a laser surgical instrument, not an AI/ML-driven diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant and was not performed.

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

Not applicable. This device is a hardware laser system. There is no mention of an algorithm or AI component that would have standalone performance.

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

The "ground truth" for the device's performance and safety is established by adherence to recognized international standards (e.g., IEC 60601 series, IEC 60825-1, IEC 62304, EN 60601-1-2) which define accepted levels of electrical safety, laser safety, EMC, usability, and software quality. Additionally, the technical specifications and established performance of legally marketed predicate devices serve as a benchmark for equivalence in tissue interaction.

8. The sample size for the training set

Not applicable. This document pertains to a hardware medical device (laser system) and does not describe any AI/ML model for which a training set would be required.

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

Not applicable. As there is no AI/ML model or training set, this question is not relevant to the provided documentation.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.

September 1, 2022

A.R.C. Laser GmbH Angela Thyzel General Manager Bessemer St. 14 Nurnberg, 90411 Germany

Re: K220531

Trade/Device Name: Fox 810 and FOX 980 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, 2022 Received: July 21, 2022

Dear Angela Thyzel:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).

Sincerely.

Jianting Wang Acting 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) K220531

Device Name FOX 810 and FOX 980

Indications for Use (Describe) FOX 810:

Indicated for surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, and pulmonology.

FOX 980:

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/3/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is stacked on top of the word "LASER", which is inside of a white rectangle. Below the rectangle is the text "enlighten your surgery" in a cursive font.

K220531 - 510(k) Summary

Submitter:	A.R.C. Laser GmbHBessemer St. 14 90411,NurembergGermany
Contact person:	Angela Thyzel, General Manager
Phone:	0911-21779-0
Fax:	0911-21779-99
E-Mail:	a.thyzel@arclaser.de
Type of 510(k):	Traditional
Date Prepared:	August 8th, 2022
Device Trade Name:	FOX 810 and FOX 980
Common Name:	Diode Laser System
Classification Name:	Laser surgical instrument for use in general and plastic surgery and indermatology
Device product code:	GEX
Device Classification:	21 CFR 878.4810
Predicate Devices:	Primary Predicates: Fox Q-980, Fox Q-1064, Fox Q-810 (K073322)Secondary Predicates: Fotona XPulse Pro Laser Platform (K202991)

Device Description:

Indications for Use:

FOX 810:

Indicated for surgical applications requiring the ablation, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, and pulmonology.

FOX 980:

Indicated for surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, pulmonology, and thoracic surgery.

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Image /page/4/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters, with the word "LASER" directly underneath in a smaller, white, rectangular box. Below that, the tagline "enlighten your surgery" is written in a cursive, handwritten-style font.

Comparison between subject and primary predicate devices Fox Q-80, Fox Q-1064 and secondary predicate device Fotona XPulse Pro Laser Platform

Specification	Subject device	Primary Predicate Device	Predicate Device
	FOX- including FOX 810 and FOX 980	Fox Q-810, Fox Q-980, Fox Q-1064	XPulse Pro Laser Platform
510(k) number	K220531	K073322	K202991
Manufacturer	A.R.C Laser GmbH	A.R.C Laser GmbH	Fotona
Regulation-Number	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
Product Code	GEX	GEX	GEX
Regulatory Class	Class II	Class II	Class II
Indications for Use	FOX 810:Indicated for surgical applicationsrequiring the ablation, vaporization,excision, incision, hemostasis, orcoagulation of soft tissues in medicalspecialties including dermatology,dentistry, gastroenterology, generalsurgery, otolaryngology, andpulmonology.FOX 980:Indicated for surgical applicationsrequiring the ablation, vaporization,excision, incision, hemostasis, orcoagulation of soft tissues in medicalspecialties including dermatology,dentistry, gastroenterology, generalsurgery, genitourinary, gynecology,otolaryngology, orthopedics,pulmonology, and thoracic surgery.	Fox Q-810:Indicated for surgical applicationsrequiring the ablation, vaporization,excision, incision, hemostasis, orcoagulation of soft tissues in medicalspecialties including dermatology,dentistry, gastroenterology, generalsurgery, neurosurgery, otolaryngology,ophthalmology, and pulmonology.Fox Q-980:Indicated for surgical applicationsrequiring the ablation, vaporization,excision, incision, hemostasis, orcoagulation of soft tissues in medicalspecialties including dermatology,dentistry, gastroenterology, generalsurgery, genitourinary, gynecology,neurosurgery, otolaryngology,orthopedics, ophthalmology,pulmonology, and thoracic surgery.	From IFU of XPulse Pro Laser Platform(partially):810 nm Diode Laser System:• Incision, excision, vaporization,ablation and coagulation of oral softtissues including the following:◦ Gingival troughing for crownimpression◦ Gingivectomy◦ Gingivoplasty◦ Gingival incision and excision◦ Hemostasis and coagulation◦ Excisional and incisional biopsies◦ Fibroma removal◦ Frenectomy and frenotomy◦ Oral papillectomies◦ Soft tissue crown lengthening◦ Treatment of aphthous ulcers◦ Treatment of herpetic lesions• Periodontology:
		Laser soft tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft tissue within the perio-dontal pocket Cosmetic Dentistry: Laser-assisted bleaching/whitening of the teeth Light activation for bleaching materials for teeth whitening Implant recovery Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or co-agulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology 980 nm Diode Laser: Gingival troughing Crown lengthening Gingivoplasty Coagulation Hemostasis of donor site Implant recovery Implant uncovery Soft tissue curettage Sulcular debridement
			Biopsy Frenectomy Operculectomy Exposure of unerupted teeth Pulpotomy Treatment of aphthous ulcers Excision of lesions Light activation of bleachingmaterials for teeth whitening Surgical applications requiring theablation, vaporization, excision,incision, hemostasis, or co-agulationof soft tissues in medical specialtiesincluding dermatology, dentistry,gastroenterolo-gy, general surgery,genitourinary, gynecology,neurosurgery, otolaryngology,orthopedics, oph-thalmology,pulmonology, and thoracic surgery.
Use of device	RX only	RX only	RX only
Laser type	Diode laser	Diode laser	Diode laser
Laser power	810nm: Up to 8 W980nm: Up to 12 W	810nm: Up to 7 W980nm: Up to 9 W	810nm: Up to 8 W980nm: Up to 12 W
Wavelength	810nm, 980nm	810nm, 980nm, 1064nm	810nm, 980nm
Laser class	4	4	4
Operation Mode	Continuous wave, pulsed, single pulse	Continuous wave, pulsed, single pulse	Continuous wave, pulsed, single pulse
Pulse length / duration	100μs – 45s	2ms - 30s	100 μs to 60 s
Pulse frequency	0.01 – 5000 Hz	0.016 – 250 Hz	0.008 Hz to 5000 Hz
Aiming beam	532nm or 650nm @ <1mW	650nm @ <2mW	Laser diode 650 nm or 532 nm ; < 1 mW
Cooling	Air	Air	Air
Delivery devices and accessories	Optical fibers 300μm, 400μm and 600μm with or without hand pieces	Optical fibers 200μm, 300μm, 400μm and 600μm with or without hand pieces	300 μm, 400 μm or 600 μm bare fiber with or without handpiece
User interface	Touchscreen and buttons	Display with rotary knob	Touch screen control
Main power supply	100V-240V, 50Hz/60Hz or battery powered	100-240 VAC, 50/60Hz or battery powered	100-240 VAC, 50/60Hz or battery powered
Dimensions	Closed stand:H 19,2 cm / W 14,2 cm / D 10,2 cmOpened Stand:H 17,4 cm / W 14.2 cm / D 16.3 cm	Closed stand:H 21,1 cm / W 11,9 cm / D 10 cmOpened stand:H 18,5 cm / W 11,9 cm / D 19,2 cm	H 17.4 cm / W 14.2 cm / D 16.3 cm with opened foot rest
Weight	1,2 kg (2.64 pounds)	1,2 kg (2.64 pounds)	1,53 kg (3.37 pounds)

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Image /page/5/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters, with the word "LASER" underneath in a smaller, bolder font. Below that, the tagline "enlighten your surgery" is written in a cursive, sans-serif font.

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Image /page/6/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters, with the word "LASER" underneath in a smaller, white, rectangular box. Below that, in a smaller font, is the phrase "enlighten your surgery" in white.

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Image /page/7/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters, with the word "LASER" directly underneath in a smaller, but still bold, white font. Below "LASER" is the tagline "enlighten your surgery" in a cursive, handwritten-style font, also in white.

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Image /page/8/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters, stacked vertically. Below that, the word "LASER" is in a white box. Underneath the box, the tagline "enlighten your surgery" is written in a smaller, cursive font.

Performance testing:

The FOX systems have been tested against

Number of Standard	Name of Standard
IEC 60601-1:2005+ COR1:2006,COR2:2007, AMD1:2012	Medical electrical equipment Part 1: General requirements forbasic safety and essential performance
IEC 60825-1:2014 (Third Edition)	Safety of Laser Products – Part 1: Equipment classification andrequirements
EN 60601-1-2:2014 (ForthEdition)	Medical electrical equipment Part 1-2: General requirementsfor safety - Collateral standard: Electromagnetic compatibility –Requirements and tests.
IEC 60601-2-22:2007 (Third Ed.)+A1:2012for use in conjunction with IEC60601-1:2005 (Third Ed.) +A1:2012	Medical electrical equipment Part 2-22: Particular requirementsfor basic safety and essential performance of surgical, cosmetic,therapeutic and diagnostic laser equipment
IEC 60601-1-6:2010/AMD1:2013for use in conjunction with IEC62366-1:2015, AMD1:2020& IEC 60601-1:2005,AMD1:2012, AMD2:2020	Medical electrical equipment Part 1-6: General requirementsfor basic safety and essential performance - Collateral standard:Usability
IEC 62304:2006 + A1:2015	Medical device software – Software life cycle process

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Image /page/9/Picture/1 description: The image features the logo for A.R.C. Laser, set against a solid blue background. The logo prominently displays the acronym "A.R.C." in bold, white letters, stacked above the word "LASER," which is also in white and enclosed in a rectangular box. Below the box, the tagline "enlighten your surgery" is written in a cursive, handwritten-style font, completing the logo's design.

Substantial Equivalence statement and conclusion

All predicate devices as well as the device under evaluation share the same wavelengths (810mm and 980nm). The wavelength is the main characteristic influencing the tissue interactions as the interaction with tissue is based on the absorption of the radiation in the corresponding chromophores. All tests conducted were done in continuous wave which can be seen as worst-case-scenario as in continuous wave the highest energy is applied. Tests for validation have also been performed for different power outputs and pulse settings.

The facts mentioned above show that the power difference between the predicate (810mm: 0,1W -7W; 980nm: 0,1W - 9W) and the device under evaluation (810nm: 0,1W - 8W; 980nm: 0,1W - 12W) does not absolutely affect the extent of incision depth and thermal tissue damage. Power alone or pulse length alone do not alter the tissue effect because for every pulse the power is set with a pulse length. These parameters, power and pulse length, equal the pulse energy when multiplied.

In addition, the predicate device XPulse Pro Laser Platform from Fotona with K-Number K202991 shares the same power output as well as similar design and functional features and therefore is equivalent with the device under evaluation.

Based to above summary, we conclude that the subject devices are as safe and effective as the predicate devices.

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.