FOX 810, FOX 980

K220531 · A.R.C Laser GmbH · GEX · Sep 1, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220531
• Device Name: FOX 810, FOX 980
• Applicant: A.R.C Laser GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FOX 810: Indicated for surgical applications requiring the ablation, vaporization, 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, excision, 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.

Device Story

FOX 810 and FOX 980 are compact diode laser systems for soft tissue surgery. Devices use laser diodes to emit 810nm or 980nm wavelengths. Operated by physicians via high-resolution touchscreen; system delivers laser energy through optical fibers (300-600μm) with or without handpieces. Operates in continuous wave, pulsed, or single-pulse modes. Energy absorption by tissue chromophores enables ablation, vaporization, excision, incision, hemostasis, or coagulation. Used in clinical settings (dermatology, dentistry, general surgery, etc.). Output allows precise tissue interaction; benefits include controlled surgical cutting and coagulation. Power supply via AC or battery.

Clinical Evidence

No clinical or animal studies were performed. Substantial equivalence is based on bench testing, including compliance with IEC 60601-1 (safety), IEC 60825-1 (laser safety), EN 60601-1-2 (EMC), IEC 60601-2-22 (laser equipment), and IEC 62304 (software).

Technological Characteristics

Diode laser system; wavelengths 810nm or 980nm; Class 4 laser. Power: up to 8W (810nm) or 12W (980nm). Operation: continuous wave, pulsed, single pulse. Cooling: air. Delivery: optical fibers (300-600μm). Interface: touchscreen. Power: 100-240V AC or battery. Standards: IEC 60601-1, IEC 60825-1, EN 60601-1-2, IEC 60601-2-22, IEC 62304.

Indications for Use

Indicated for surgical soft tissue ablation, vaporization, excision, incision, hemostasis, or coagulation. FOX 810 specialties: dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, pulmonology. FOX 980 specialties: dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, pulmonology, thoracic surgery.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Fox Q-980, Fox Q-1064, Fox Q-810 (K073322)
• Fotona XPulse Pro Laser Platform (K202991)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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:

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.

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 GmbH<br>Bessemer St. 14 90411,<br>Nuremberg<br>Germany |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Angela Thyzel, General Manager |
| Phone: | 0911-21779-0 |
| Fax: | 0911-21779-99 |
| E-Mail: | [e-mail] |
| 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 in<br>dermatology |
| Device product code: | GEX |
| Device Classification: | 21 CFR 878.4810 |
| Predicate Devices: | Primary Predicates: Fox Q-980, Fox Q-1064, Fox Q-810 (K073322)<br>Secondary Predicates: Fotona XPulse Pro Laser Platform (K202991) |

#### 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.

#### 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:<br>Indicated for surgical applications<br>requiring the ablation, vaporization,<br>excision, incision, hemostasis, or<br>coagulation of soft tissues in medical<br>specialties including dermatology,<br>dentistry, gastroenterology, general<br>surgery, otolaryngology, and<br>pulmonology.<br>FOX 980:<br>Indicated for surgical applications<br>requiring the ablation, vaporization,<br>excision, incision, hemostasis, or<br>coagulation of soft tissues in medical<br>specialties including dermatology,<br>dentistry, gastroenterology, general<br>surgery, genitourinary, gynecology,<br>otolaryngology, orthopedics,<br>pulmonology, and thoracic surgery. | Fox Q-810:<br>Indicated for surgical applications<br>requiring the ablation, vaporization,<br>excision, incision, hemostasis, or<br>coagulation of soft tissues in medical<br>specialties including dermatology,<br>dentistry, gastroenterology, general<br>surgery, neurosurgery, otolaryngology,<br>ophthalmology, and pulmonology.<br>Fox Q-980:<br>Indicated for surgical applications<br>requiring the ablation, vaporization,<br>excision, incision, hemostasis, or<br>coagulation of soft tissues in medical<br>specialties including dermatology,<br>dentistry, gastroenterology, general<br>surgery, genitourinary, gynecology,<br>neurosurgery, otolaryngology,<br>orthopedics, ophthalmology,<br>pulmonology, and thoracic surgery. | From IFU of XPulse Pro Laser Platform<br>(partially):<br><br>810 nm Diode Laser System:<br>• Incision, excision, vaporization,<br>ablation and coagulation of oral soft<br>tissues including the following:<br>◦ Gingival troughing for crown<br>impression<br>◦ Gingivectomy<br>◦ Gingivoplasty<br>◦ Gingival incision and excision<br>◦ Hemostasis and coagulation<br>◦ Excisional and incisional biopsies<br>◦ Fibroma removal<br>◦ Frenectomy and frenotomy<br>◦ Oral papillectomies<br>◦ Soft tissue crown lengthening<br>◦ Treatment of aphthous ulcers<br>◦ Treatment of herpetic lesions<br>• 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 bleaching<br>materials for teeth whitening Surgical applications requiring the<br>ablation, vaporization, excision,<br>incision, hemostasis, or co-agulation<br>of soft tissues in medical specialties<br>including dermatology, dentistry,<br>gastroenterolo-gy, general surgery,<br>genitourinary, gynecology,<br>neurosurgery, otolaryngology,<br>orthopedics, oph-thalmology,<br>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 W<br>980nm: Up to 12 W | 810nm: Up to 7 W<br>980nm: Up to 9 W | 810nm: Up to 8 W<br>980nm: 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:<br>H 19,2 cm / W 14,2 cm / D 10,2 cm<br>Opened Stand:<br>H 17,4 cm / W 14.2 cm / D 16.3 cm | Closed stand:<br>H 21,1 cm / W 11,9 cm / D 10 cm<br>Opened stand:<br>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,<br>COR2:2007, AMD1:2012 | Medical electrical equipment Part 1: General requirements for<br>basic safety and essential performance |
| IEC 60825-1:2014 (Third Edition) | Safety of Laser Products – Part 1: Equipment classification and<br>requirements |
| EN 60601-1-2:2014 (Forth<br>Edition) | Medical electrical equipment Part 1-2: General requirements<br>for safety - Collateral standard: Electromagnetic compatibility –<br>Requirements and tests. |
| IEC 60601-2-22:2007 (Third Ed.)<br>+A1:2012<br>for use in conjunction with IEC<br>60601-1:2005 (Third Ed.) +<br>A1:2012 | Medical electrical equipment Part 2-22: Particular requirements<br>for basic safety and essential performance of surgical, cosmetic,<br>therapeutic and diagnostic laser equipment |
| IEC 60601-1-6:2010/<br>AMD1:2013<br>for use in conjunction with IEC<br>62366-1:2015, AMD1:2020<br>& IEC 60601-1:2005,<br>AMD1:2012, AMD2:2020 | Medical electrical equipment Part 1-6: General requirements<br>for basic safety and essential performance - Collateral standard:<br>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