(121 days)
Not Found
No
The document describes a laser system for various surgical and therapeutic applications. There is no mention of AI or ML in the intended use, device description, or performance studies. The device appears to be a hardware-based laser system with a standard control interface.
Yes
The "Intended Use / Indications for Use" section explicitly lists "1064 nm Diode Laser in therapy" and "810 nm Diode Laser in therapy" for various pain relief and circulation promotion purposes, which are therapeutic applications.
No
This device is a surgical and therapeutic laser system used for various procedures like incision, excision, vaporization, and pain relief. Its intended uses do not involve the detection, diagnosis, or monitoring of diseases or conditions.
No
The device description clearly describes a hardware system including a console, footswitch, laser beams, optical fiber delivery system, and handpieces. It is a physical laser system, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended uses and device description clearly indicate that this laser system is used for direct treatment and procedures on the patient's body (soft tissue, teeth, nails, muscles, joints). It does not involve the analysis of samples like blood, urine, or tissue outside of the body.
- The device description focuses on the laser technology and its application to tissue. It describes the wavelengths, delivery system, and handpieces used for surgical and therapeutic purposes. This is consistent with a medical device used for treatment, not diagnosis based on in vitro analysis.
- The intended uses are all clinical procedures. The list of indications includes surgical procedures (excision, vaporization, coagulation), therapeutic applications (pain relief, blood circulation), and dental procedures (gingivectomy, root canal adjunct). These are all actions performed directly on the patient.
Therefore, the Fotona XPulse Laser System Family, as described, is a therapeutic and surgical medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
1064 nm Diode Laser in dentistry:
- · Excisional and incisional biopsies
- · Excision and vaporization of herpes simplex I and II
- · Frenectomy and frenotomy
- · Gingivectomy
- Gingivoplasty
- · Gingival incision and excision
- · Hemostasis
- · Implant recovery
- · Operculectomy
- Pulpotomy and pulpotomy as an adjunct to root canal therapy
- · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
- · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility)
- · Treatment of aphthous ulcers and herpetic lesions
1064 nm Diode Laser in dermatology and other surgical areas:
· General surgery indications: surgical incision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, menibrane, lymph vessels and nodes, organs and glands, fibroma removal.
• Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.
· Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.)
1064 nm Diode Laser in therapy:
· Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.
810 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology
- · Oral/Maxillofacial Indications: Incision, excision, vaporization, ablation and/or coagulation of soft tissue
- · 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, inflamed and necrosed soft tissue within the periodontal pocket
- Cosmetic Dentistry:
- 。 Laser-assisted bleaching/whitening of the teeth
- · Light activation for bleaching materials for teeth whitening
- Implant recovery
810 nm Diode Laser in therapy:
· Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
980 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology and thoracic surgery
- Gingival troughing
- Crown lengthening
- Gingivoplasty
- · Coagulation
- Implant uncovery
- Implant recovery
- Soft tissue curettage
- Sulcular debridement
- · Biopsy
- · Frenectomy
- Hemostasis of donor site
- Operculectomy
- Exposure of unerupted teeth
- Pulpotomy
- Treatment of aphthous ulcers
- · Excision of lesions
- · Light activation of bleaching materials for teeth whitening
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Fotona XPulse Laser System Family is a multi-application, multi-technology laser system family that supports the diode laser technology. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.
The Fotona XPulse Laser System Family consists of a console and a footswitch. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen.
A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The following wavelengths are currently available with the XPulse System Family: 810 nm, 980 nm and 1064 nm.
The following handpieces are to be used with Fotona XPulse Laser System Family: R21 (variants C2, C3, SHP and EHP), R26 (variants: black, green, blue, silver and red), Genova- and MarcCo (variants S, M and L).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, striated and smooth tissue, muscle, cartillage, menibrane, lymph vessels and nodes, organs and glands, fibroma, periodontal pocket, aphthous ulcers, herpetic lesions, nail, muscle, joint, gingiva, dental pulp, periapical area, periodontal pocket, oral soft tissue, teeth.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing: No clinical testing was needed.
Laboratory testing was conducted to support that the proposed XPulse Laser System Family meets all design specifications and that it is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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 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.
October 12, 2022
Fotona d.o.o. Marko Berdajs Quality Assurance and Regulatory Affairs Manager Stegne 7 Ljubljana, 1000 Slovenia
Re: K221712
Trade/Device Name: Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) 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: June 10, 2022 Received: June 13, 2022
Dear Marko Berdajs:
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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221712
Device Name
Fotona XPulse Laser System Family
Indications for Use (Describe)
1064 nm Diode Laser in dentistry:
- · Excisional and incisional biopsies
- · Excision and vaporization of herpes simplex I and II
- · Frenectomy and frenotomy
- · Gingivectomy
- Gingivoplasty
- · Gingival incision and excision
- · Hemostasis
- · Implant recovery
- · Operculectomy
- Pulpotomy and pulpotomy as an adjunct to root canal therapy
- · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy
- · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility)
- · Treatment of aphthous ulcers and herpetic lesions
1064 nm Diode Laser in dermatology and other surgical areas:
· General surgery indications: surgical incision, vaporization and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartillage, menibrane, lymph vessels and nodes, organs and glands, fibroma removal.
• Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.
· Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.)
1064 nm Diode Laser in therapy:
· Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.
810 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology
- · Oral/Maxillofacial Indications: Incision, excision, vaporization, ablation and/or coagulation of soft tissue
- · Gingival troughing for crown impression
- · Gingivectomy
- Gingivoplasty
- 。 Gingival incision and excision
- 。 Hemostasis and coagulation
- · Excisional and incisional biopsies
- Fibroma removal
- 。 Frenectomy and frenotomy
3
- 。 Oral papillectomies
- · Soft tissue crown lengthening
- 。 Treatment of aphthous ulcers
- 。 Treatment of herpetic lesions
- · Periodontology:
- · Laser soft tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Cosmetic Dentistry:
- 。 Laser-assisted bleaching/whitening of the teeth
- · Light activation for bleaching materials for teeth whitening
- Implant recovery
810 nm Diode Laser in therapy:
· Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
980 nm Diode Laser in dentistry:
· Surgical applications requiring the ablation, vaporization, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology and thoracic surgery
- Gingival troughing
- Crown lengthening
- Gingivoplasty
- · Coagulation
- Implant uncovery
- Implant recovery
- Soft tissue curettage
- Sulcular debridement
- · Biopsy
- · Frenectomy
- Hemostasis of donor site
- Operculectomy
- Exposure of unerupted teeth
- Pulpotomy
- Treatment of aphthous ulcers
- · Excision of lesions
- · Light activation of bleaching materials for teeth whitening
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
510(k) Summary
SUBMITTER'S INFORMATION
| Submitter: | Fotona d.o.o.
Stegne 7
1000 Ljubljana, Slovenia |
|-----------------|-----------------------------------------------------------------|
| | Phone: +386 1 5009 100 |
| | Fax: +386 1 5009 200 |
| Contact Person: | Marko Berdajs, Quality Assurance and Regulatory Affairs Manager |
| | Phone: + 386 1 5009 119 |
| | E-mail: marko.berdajs@fotona.com |
| Date: | June 10, 2022 |
DEVICE INFORMATION
| Device Trade Name: | Fotona XPulse Laser System Family |
|---|---|
| Common name: | Medical Laser System |
| Classification name: | GEX-Powered Laser Surgical Instrument, General and Plastic Surgery |
| 21 CFR 878.4810, Class II | |
| Product Code: | GEX |
PREDICATE DEVICES
- Fotona SkyPulse Laser Platform (K193656) •
- Fotona XPulse Pro Laser Platform (K202991) •
- Fotona LightWalker Laser System Family (K202985) •
6
K221712
DEVICE DESCRIPTION
The Fotona XPulse Laser System Family is a multi-application, multi-technology laser system family that supports the diode laser technology. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end.
The Fotona XPulse Laser System Family consists of a console and a footswitch. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen.
A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The following wavelengths are currently available with the XPulse System Family: 810 nm, 980 nm and 1064 nm.
The following handpieces are to be used with Fotona XPulse Laser System Family: R21 (variants C2, C3, SHP and EHP), R26 (variants: black, green, blue, silver and red), Genova- and MarcCo (variants S, M and L).
INDICATIONS FOR USE
1064 nm Diode Laser in dentistry:
- Excisional and incisional biopsies .
- . Excision and vaporization of herpes simplex I and II
- Frenectomy and frenotomy .
- Gingivectomy .
- Gingivoplasty .
- . Gingival incision and excision
- . Hemostasis
- . Implant recovery
- Operculectomy .
- . Pulpotomy and pulpotomy as an adjunct to root canal therapy
- Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy .
- Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the . periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility)
- . Treatment of aphthous ulcers and herpetic lesions
1064 nm Diode Laser in dermatology and other surgical areas:
- General surgery indications: surgical incision, excision, vaporization and coagulation of soft tissue. . All soft tissue is included, striated and smooth tissue, muscle, cartillage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal.
- . Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: Matrixectomy, Periungual and subungual warts, Plantar warts, Radical nail excision, Neuromas.
- Temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes Trichophyton . rubrum and T mentagrophytes and/or yeasts Candida albicans, etc.)
1064 nm Diode Laser in therapy:
- . Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.
7
K221712
810 nm Diode Laser in dentistry:
- 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
- . Oral/maxillofacial Indications: Incision, excision, vaporization, ablation and coagulation of oral soft tissue
- o Gingival troughing for crown impression
- Gingivectomy o
- ە Gingivoplasty
- ﻩ Gingival incision and excision
- Hemostasis and coagulation o
- o Excisional and incisional biopsies
- Fibroma removal o
- o Frenectomy and frenotomy
- o Oral papillectomies
- Soft tissue crown lengthening o
- ە Treatment of aphthous ulcers
- Treatment of herpetic lesions o
- . Periodontology:
- ە Laser soft tissue curettage,
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal ە pocket
- . Cosmetic Dentistry:
- Laser-assisted bleaching/whitening of the teeth,
- Light activation for bleaching materials for teeth whitening o
- . Implant recovery
810 nm Diode Laser in therapy:
- Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
980 nm Diode Laser:
- Surgical applications requiring the ablation, vaporization, excision, 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
- . Gingival troughing
- . Crown lengthening
- Gingivoplasty •
- Coagulation •
- Implant recovery
- Implant uncovery
- . Soft tissue curettage
- . Sulcular debridement
- Biopsy
- . Frenectomy
- . Hemostasis of donor site
- . Operculectomy
- Exposure of unerupted teeth .
- Pulpotomy .
8
- Treatment of aphthous ulcers .
- Excision of lesions ·
- Light activation of bleaching materials for teeth whitening •
9
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The Fotona XPulse Laser System Family has either identical or similar applicable technological and design characteristics (design, chemical composition, energy source, wavelength, active medium, power supply, beam delivery, controls, housing) as the previously cleared Fotona SkyPulse Laser Platform (K193656), Fotona LightWalker Laser System Family (K202985) and Fotona XPulse Pro Laser Platform (K202991).
The output characteristics of the proposed device are similar to those of the proposed intended use. All of the devices utilize class I aiming beams that pose a minimal hazard to the user when the devices are used properly. All systems are microprocessor controlled devices. The microprocessor control regulates normal operation, permits parameter selection and avoids hazard incidence.
A comparison of the technical specifications of the XPulse Laser System Family with the previously cleared devices is provided in tables below:
| | Fotona SkyPulse Laser
Platform
(K193656) | Fotona LightWalker Laser
System Family
(K202985) | XPulse Laser System Family
(This submission) |
|--------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Energy source | Solid state diode | Solid state Nd:YAG | Solid state diode |
| Wavelength | 1064 nm | 1064 nm | 1064 nm |
| Aiming beam | Laser diode 635 nm/650 nm
(red);