(117 days)
The Fotona XD Diode Laser System, and its accessories, are intended for use in
- Periodontology for
- Laser soft tissue curettage r
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Oral Soft Tissue surgery for
- Gingivectomy
- Gingivoplasty
- Fibroma removal
- Treatment of Aphthous Ulcers
- Crown Lenghtening
- Frenectomy
- Papillectomy
- Photocoagulation
- Cosmetic Dentistry for
- Light activation for bleaching materials for teeth whitening -
- Lasers-assisted bleaching/whitening of the teeth -
The Fotona XD Diode Laser System is based on a semiconductor laser that operates in the nearinfrared range of the electromagnetic spectrum. The laser source consists of a compact semiconductor laser diode module that emits laser light at a wavelength of 810 nm in continuous wave mode or pulse operation mode from 20 Hz to 10 kHz. The output power can be set from 250 m W to 7.0W. A red diode aiming beam (650 nm) is combined with the therapeutic laser beam and , both beams are guided through an optical fiber delivery unit and an optical handpiece to the treatment site.
The provided text describes a 510(k) submission for the Fotona XD Diode Laser System, seeking substantial equivalence to existing predicate devices. This type of submission relies on demonstrating that a new device is "as safe and effective" as a legally marketed predicate device, rather than requiring a detailed study proving performance against specific acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria and a study to prove device performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document. The document focuses on regulatory clearance through substantial equivalence.
Here's an explanation of what can be extracted and why other parts are not available:
1. A table of acceptance criteria and the reported device performance
Not applicable. The 510(k) summary does not present specific acceptance criteria in terms of quantitative performance metrics for the Fotona XD Diode Laser System itself. Instead, it relies on demonstrating substantial equivalence to predicate devices that have already met safety and effectiveness standards. The "device performance" is implicitly considered to be equivalent to the predicate devices for the specified indications for use.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No new clinical trials or performance studies with test sets are described in this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No new test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document pertains to a medical device (laser system), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI-related performance improvements are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable to this 510(k) submission directly. The "ground truth" for the Fotona XD Diode Laser System's approval is based on the established safety and effectiveness of the legally marketed predicate devices for their approved indications.
8. The sample size for the training set
Not applicable. No machine learning or AI component requiring a training set is part of this device or its submission.
9. How the ground truth for the training set was established
Not applicable. No machine learning or AI component requiring a training set is part of this device or its submission.
Summary of Relevant Information from the Provided Text:
The essence of this 510(k) submission is to demonstrate substantial equivalence to existing devices, specifically:
- Predicate Device 1: Odyssey 2.4G Diode Laser (K050453)
- Predicate Device 2: Opus 10 Dental Diode Laser System (With Tooth Whitening Application) (K011769)
The Fotona XD Diode Laser System shares the same indications for use and similar design and functional features with these predicate devices. The approval letter from the FDA (FEB - 4 2009) confirms that the device is "substantially equivalent" to legally marketed predicate devices, thereby allowing it to proceed to market. This indicates that the device met the regulatory requirements for 510(k) clearance by proving its similarity to already approved devices, rather than through a de novo performance study against specific acceptance criteria.
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KD.83034
Page (1) of (2)
FEB ~ 4 2009
5. 510(k) Summary
Submitter's Name:
Fotona d.d. Stegne 7 1210 Ljubljana, Slovenia Phone: +386 15009100 + 386 5009 200 Fax: Stojan Trošt, QA&RA Manager Phone: + 386 1 5009 299 E-mail: stojan trost@fotona.com
Contact Person:
Date: October 8, 2008
Device Name: Trade name: Common name: Classification name:
Fotona XD Diode Laser System Diode Surgical Laser Instruments, Surgical, Powered, Laser 79-GEX
DEVICE DESCRIPTION
The Fotona XD Diode Laser System is based on a semiconductor laser that operates in the nearinfrared range of the electromagnetic spectrum. The laser source consists of a compact semiconductor laser diode module that emits laser light at a wavelength of 810 nm in continuous wave mode or pulse operation mode from 20 Hz to 10 kHz. The output power can be set from 250 m W to 7.0W. A red diode aiming beam (650 nm) is combined with the therapeutic laser beam and , both beams are guided through an optical fiber delivery unit and an optical handpiece to the treatment site.
INTENDED USE
The Fotona XD Diode Laser System, and its accessories, are intended for use in
- Periodontology for
- Laser soft tissue curettage r
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Oral Soft Tissue surgery for
- Gingivectomy
- Gingivoplasty
- Fibroma removal
- Treatment of Aphthous Ulcers
- Crown Lenghtening
- Frenectomy
- Papillectomy
- Photocoagulation
510(k) Submission Fotona XD Diode Laser System / v2
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KU8303X Page (1) of (2)
- Cosmetic Dentistry for
- Light activation for bleaching materials for teeth whitening -
- Lasers-assisted bleaching/whitening of the teeth -
STATEMENT OF SUBSTANTIAL EQUIVALENCE
The Fotona XD Diode Laser System shares the same indications for use, similar design and functional features with, and therefore Fotona d.d. believes that its Fotona XD Laser System is substantially equivalent to, the
a) Odyssey 2.4G Diode Laser (K050453) previously cleared for a variety of surgical procedures on soft tissue within the oral cavity;
b) Opus 10 Dental Diode Laser System (With Tooth Whitening Application) (K011769) previously cleared for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening.
Details are provided in the Substantial Equivalence Discussion Section of this submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles an abstract eagle or bird-like figure.
Public Health Service
FEB - 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fotona D.D. % Mr. Stojan Trost Stegne 7 Ljubljana Slovenia 1210
Re: K083034
Trade/Device Name: Fotona XD Diode Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX
Dated: January 19, 2009 Received: January 23, 2009
Dear Mr. Trost:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Milburn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use Statement
510(k) Number (if known):
083034
Device Name: Fotona XD Diode Laser System
Indications For Use:
Periodontology
- Laser soft tissue curettage --
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
Oral Soft Tissue surgery
- Gingivectomy ﯩﭗ
- Gingivoplasty
- Fibroma removal
- Treatment of Aphthous Ulcers
- Crown Lenghtening
- . Frenectomy
- Papillectomy
- Photocoagulation
Cosmetic Dentistry
- Light activation for bleaching materials for teeth whitening
- Lasers-assisted bleaching/whitening of the teeth
Prescription Use: X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
510(k) Submission Fotona XD Diode Laser System / v2
§ 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.