(265 days)
Not Found
No
The document describes a laser platform with different wavelengths and handpieces for various surgical and therapeutic applications. There is no mention of AI or ML in the intended use, device description, or performance studies. The control is described as a touch-screen interface to a microcontroller, which is standard for medical devices and does not imply AI/ML.
Yes
The device is described as a "multi-application, multi-technology platform" that provides "therapy" through its diode laser modules for indications such as "temporary relief of minor muscle and joint pain and stiffness," and various surgical and cosmetic applications.
No
The device is a multi-application laser platform used for surgical procedures like incision, excision, vaporization, and coagulation of soft tissues, as well as therapeutic applications like pain relief and teeth whitening. While it can be used for biopsies, which can aid in diagnosis, its primary function is not diagnostic but rather interventional and therapeutic.
No
The device description clearly states it is a "multi-application, multi-technology platform that supports the diode laser technology" and includes physical components like a console, footswitch, attachable laser modules, optical fiber delivery system, and handpieces. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Fotona XPulse Pro Laser Platform is a surgical and therapeutic laser system. Its intended uses involve direct interaction with the patient's tissues for procedures like cutting, removing, coagulating, and treating various conditions. It also includes applications like teeth whitening and pain relief.
- Lack of Specimen Analysis: The description and intended uses do not mention the analysis of any biological specimens taken from the body. The device operates directly on the patient.
Therefore, the Fotona XPulse Pro Laser Platform falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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, 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
- · Surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology
810 nm Diode Laser Module:
· Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
- 。 Gingival troughing for crown impression
- · Gingivoplasty
- · Soft tissue crown lengthening
- 。 Treatment of aphthous ulcers
- 。 Treatment of herpetic lesions
810 nm Diode Laser System & Module 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:
- · 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, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, and thoracic surgery.
445 nm Diode Laser:
· Incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Fotona XPulse Pro Laser Platform is a multi-application, multi-technology platform 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 Pro Laser Platform consists of a console, a footswitch and attachable laser modules. 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 platform: 445 nm, 810 mm and 980 nm.
Following handpieces are to be used with Fotona Xpulse Pro Laser Platform: R21-SHP, R26 (variants: black, green, blue, silver and red), R24, R30, Genova and MarcCo (variants S, M & L).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral soft tissues, periodontal pocket, implant, teeth, soft tissues (in specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, pulmonology, genitourinary, gynecology, orthopedics, thoracic surgery), minor muscle and joint.
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
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 Pro Laser Platform 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.
K193656, K073322, K192272, K180044, K083034
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 22, 2021
Fotona d.o.o. Marko Berdajs Quality Assurance and Regulatory Affairs Manager Stegne 7 Ljubljana, 1000 Slovenia
Re: K202991
Trade/Device Name: Fotona XPulse Pro Laser Platform 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: September 30, 2020 Received: September 30, 2020
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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.
Purva Pandya 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
2
Indications for Use
510(k) Number (if known) K202991
Device Name XPulse Pro Laser Platform
Indications for Use (Describe)
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, 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
- · Surgical applications requiring the ablation, vaporization, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology
810 nm Diode Laser Module:
· Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
- 。 Gingival troughing for crown impression
- · Gingivoplasty
- · Soft tissue crown lengthening
- 。 Treatment of aphthous ulcers
- 。 Treatment of herpetic lesions
810 nm Diode Laser System & Module 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:
- · Gingival troughing
- · Crown lengthening
- · Gingivoplasty
- · Coagulation
3
- 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, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, and thoracic surgery.
445 nm Diode Laser:
· Incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue
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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4
510(k) Summary K202991 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 21, 2021 |
DEVICE INFORMATION
| Device Trade Name: | Fotona XPulse Pro Laser Platform |
|---|---|
| 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)
- . FOX 1-980, FOX Q-1064, FOX-Q-810 (K073322)
- Wolf445nm (K192272)
- SIROLaser Blue (K180044)
- XD Diode Laser System (K083034)
5
DEVICE DESCRIPTION
The Fotona XPulse Pro Laser Platform is a multi-application, multi-technology platform 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 Pro Laser Platform consists of a console, a footswitch and attachable laser modules. 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 platform: 445 nm, 810 mm and 980 nm.
Following handpieces are to be used with Fotona Xpulse Pro Laser Platform: R21-SHP, R26 (variants: black, green, blue, silver and red), R24, R30, Genova and MarcCo (variants S, M & L).
INTENDED USE
810 nm Diode Laser System:
- Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
- o Gingival troughing for crown impression
- o Gingivectomy
- Gingivoplasty o
- o Gingival incision and excision
- Hemostasis and coagulation O
- o Excisional and incisional biopsies
- o Fibroma removal
- Frenectomy and frenotomy o
- Oral papillectomies o
- Soft tissue crown lengthening o
- Treatment of aphthous ulcers o
- o Treatment of herpetic lesions
- Periodontology: .
- o Laser soft tissue curettage,
- o Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Cosmetic Dentistry: .
- Laser-assisted bleaching/whitening of the teeth, o
- Light activation for bleaching materials for teeth whitening o
- . Implant recovery
- 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
6
810 nm Diode Laser Module:
- Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
- Gingival troughing for crown impression o
- Gingivoplasty o
- o Soft tissue crown lengthening
- o Treatment of aphthous ulcers
- Treatment of herpetic lesions o
810 nm Diode Laser System & Module 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:
- 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 coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics. ophthalmology, pulmonology, and thoracic surgery.
445 nm Diode Laser:
- Incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue
7
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The Fotona XPulse Pro Laser Platform 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), FOX 1-980, FOX Q-1064, FOX-Q-810 (K073322), Wolf445nm (K192272), XD Diode Laser System (K083034) and SIROLaser Blue (K180044).
The output characteristics of the proposed device are similar to those of the predicate devices for 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 platform with the previously cleared devices is provided in tabels below:
| | XD Diode Laser System
(K083034) | Fotona SkyPulse Laser
Platform
(K193656) | Fotona XPulse Pro Laser
Platform
(this submission) |
|-----------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Energy source | Diode | Diode | Diode |
| Wavelength | $810 \pm 10$ nm | 808 nm | 810 nm |
| Power | Up to 7 W | 0.1-33 W | Up to 8 W (system)
Up to 1.5 W (module) |
| Pulse width | 0.025 - 25 ms; CW | 10 ms - 10 s; CW | 20 $\mu$ s to 30 s, CW |
| Repetition rate | CW or 20 Hz - 10 kHz | CW or up to 100 Hz | CW, 0.1 Hz to 200 Hz |
| Delivery system | Contact and non-contact
handpieces connected to the
system via fiber | Contact and non-contact
handpieces connected to the
system via fiber | Contact and non-contact
handpieces connected to the
system via fiber |
| User interface | Button control | Touch screen control | Touch screen control |
Table 1: Comparison table of the technical specifications of Fotona XPulse Pro Laser Platform with the previously cleared devices for the wavelength of 810 nm
Table 2: Comparison table of the technical specifications of Fotona XPulse Pro Laser Platform with the previously cleared devices for the wavelength of 980 nm.
| | Fotona SkyPulse Laser Platform
(K193656) | Fotona XPulse Pro Laser Platform
(this submission) | |
|-----------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|--|
| Energy source | Diode | Diode | |
| Wavelength | 980 nm | 980 nm | |
| Aiming beam | Laser diode 635 nm/650 nm (red) ; 4 Watt: 0.02 Hz to 6.6 Hz and
CW | 1 Hz to 10 kHz | CW, 0.1 Hz to 200 Hz |
| Delivery system | Optical fibers 300 um, 400 um and
600 um with or without handpieces | Delivery devices, fibers 200 mm,
320 mm | 300 um, 400 um or 600 um bare
fiber with or without handpiece
R21 and R21-SHP |
9
TESTING
Clinical testing: No clinical testing was needed.
Fotona XPulse Pro Laser Platform is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards:
ISO 14971:2007 Medical devices - Application of risk management to medical devices
IEC 60601-1:2005 + A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic disturbances - Requirements and tests.
IEC 62304:2006 + A1:2015 Medical device software - Software life-cycle processes.
IEC 60601-1-6:2010 + A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
IEC 62366:2007 + A1:2014 Medical devices - Application of usability engineering to medical devices.
IEC 60601-2-22:2007 + A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
Laboratory testing was conducted to support that the proposed Xpulse Pro Laser Platform meets all design specifications and that it is substantially equivalent to the predicate devices.
10
STATEMENT OF SUBSTANTIAL EQUIVALENCE
The XPulse Pro Laser Platform shares the same indications for use, similar design and functional features with predicate devices, and therefore Fotona believes that its XPulse Pro Laser Platform is substantially equivalent to the Fotona SkyPulse Laser Platform (K193656), Fox Q-810, Q-980 and Q-1064(K073322),Wolf 445nm (K192272), XD Diode Laser System (K083034) and SIROLaser Blue (K180044).
Based on its technical characteristics, performance test data, and its indications for use, the Fotona XPulse Pro Laser Platform is found to be substantially equivalent to the predicate devices.