(189 days)
Not Found
No
The document describes a laser system with a diode beam source and touchscreen control, with no mention of AI, ML, or related concepts.
Yes
The device is indicated for surgical applications requiring ablation, vaporization, hemostasis, or coagulation of soft tissues, which are therapeutic actions designed to treat medical conditions.
No
The device description and intended use clearly state that the FOX Lasers are indicated for surgical applications that involve ablation, vaporization, hemostasis, or coagulation of soft tissues. These are therapeutic, not diagnostic, procedures.
No
The device description explicitly states it is a "compact diode laser with a high-resolution color touchscreen," indicating it is a hardware device that emits a laser beam for surgical applications.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical applications involving the ablation, vaporization, hemostasis, or coagulation of soft tissues within the body. IVDs are used to examine specimens from the body (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a laser system designed to deliver energy to tissue. This is a therapeutic or surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
The device is a surgical laser intended for direct application to tissue during medical procedures.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The FOX systems have been tested against:
- IEC 60601-1:2005+ COR1:2006, COR2:2007, AMD1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60825-1:2014 (Third Edition) Safety of Laser Products – Part 1: Equipment classification and requirements
- EN 60601-1-2:2014 (Forth Edition) Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility – Requirements and tests.
- IEC 60601-2-22:2007 (Third Ed.) +A1:2012 for use in conjunction with IEC 60601-1:2005 (Third Ed.) + A1:2012 Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60601-1-6:2010/AMD1:2013 for use in conjunction with IEC 62366-1:2015, AMD1:2020 & IEC 60601-1:2005, AMD1:2012, AMD2:2020 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62304:2006 + A1:2015 Medical device software – Software life cycle process
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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
1
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:
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
Bessemer St. 14 90411,
Nuremberg
Germany |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 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 in
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)
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: | ||
| 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, 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, | |||
| otolaryngology, orthopedics, | |||
| pulmonology, and thoracic surgery. | Fox Q-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, | |||
| ophthalmology, and pulmonology. | |||
| Fox Q-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, 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 soft
tissues including the following:
◦ Gingival troughing for crown
impression
◦ 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 bleaching
materials for teeth whitening Surgical applications requiring the
ablation, vaporization, excision,
incision, hemostasis, or co-agulation
of soft tissues in medical specialties
including 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 W
980nm: Up to 12 W | 810nm: Up to 7 W
980nm: Up to 9 W | 810nm: Up to 8 W
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 @