The FotonA Dualis "KTP laser is intended for incision, ablation, vaporization, coacjulation, and hemostasis of vascular lesions and soft tissue in vanous surgical areas. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands. Dermatology : The treatment (hemostasis, color lightening, flattening, reduction of lesion size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia). The Fotona Dualis Er:YAG laser is intended for surgical incision/excision, variorization and coaqulation of soft and hard tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, cartilage meniscus, mucous membrane, lymplı vessels and nodes, organs and glands. Dermatology an Plastic Surgery Indications: Epidermal nevi, telangiectasias, spider veins, actinic sheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, decubitis ulcers, and skin resurfacing. ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia Gynecology Indications: Herpes simplex, endomaterial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, and condiloma. General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation. Oral/Maxillofacial Indications: Oral and glossal lesions and gingivectorny Ophtalmology Indications: Soft tissue surrounding the eye and orbit and anterior capsulotomy Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae and matrixectomy Dentistry indications: Caries removal, cavity preparation, enamel etching

Device Description

The Fotona Dualis " laser system is based on the Er: YAG (2940 nm) and KTP (532 nm) laser technology. It is modification to combine two lasers into one housing. The unmodified devices are the Fotona Fidelis Er:YAG laser and the Fotona Dualis " KTP laser system. There are two optical cavities containing the KTP and Er:Y.AG crystals, Both are activated by means of the use of flashlamps. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided: - In case of the KTP laser through an optical fiber delivery system to a focusing . handpiece. - . In case of the Er: Y AG laser through articulated arm to a focusing handpiece. Both lasers share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Er.YAG laser source or the KTP laser source. When the laser is first turned on the physician is able to select the desired wavelength via control panel.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The provided document (a 510(k) premarket notification) does not define specific, quantifiable acceptance criteria in the typical sense (e.g., minimum sensitivity, specificity, or accuracy levels). Instead, the core acceptance criterion for the Fotona Dualis® Er:YAG/KTP Laser System is "Substantial Equivalence" to previously cleared predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Implicit)	Description	Reported Device Performance
Substantial Equivalence to Predicate Devices	The device must be demonstrated to be as safe and effective as a legally marketed predicate device(s). This implicitly means demonstrating similar performance characteristics, intended use, technological characteristics, and safety profiles. The specific predicate devices are: - Fotona DualisVP long pulse KTP laser system - Fotona Fidelis Er:YAG laser system	Fotona believes its Dualis® laser system is substantially equivalent because: - Intended Use: The Fotona Dualis®'s intended uses for both KTP and Er:YAG lasers are the same as those of their respective predicate devices. - Design Features: Shares the same design features (wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing) as the predicate devices. - Output Characteristics: The output characteristics are the same as those of the predicate devices. - Risk and Benefits: Risk and benefits for the Dualis® laser system are comparable to the predicate devices when used for similar clinical applications. Conclusion: "It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of the Dualis® Er:YAG/KTP laser system." The FDA's letter concurs with this finding of substantial equivalence.

Study Information:

Based on the provided document, the "study" conducted to demonstrate substantial equivalence is a comparative analysis of the new device's technical specifications and intended use against those of legally marketed predicate devices, rather than a clinical trial with performance metrics.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. This submission relies on a comparison to existing devices, not a new clinical trial with a defined "test set" of patient data.
- Data Provenance: Not applicable. No new patient data was generated or analyzed for this 510(k) submission. The provenance would refer to the data supporting the predicate devices' clearances, which is not detailed here.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. There was no "test set" requiring ground truth established by experts in the context of a performance study. The "ground truth" here is the established safety and effectiveness of the predicate devices as determined by their previous clearances.
Adjudication Method for the Test Set:
- Not applicable. No "test set" or adjudication of results was performed. The regulatory body (FDA) reviewed the manufacturer's comparison to predicate devices.
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:
- No. This is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device (laser system), not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this substantial equivalence determination is the regulatory clearance and established safety and effectiveness of the predicate devices as proven through their own previous regulatory filings and real-world clinical use.
The Sample Size for the Training Set:
- Not applicable. This submission does not involve machine learning or AI, and therefore no "training set" in that context. The "training" for this device's design and manufacturing would come from established engineering principles and data from the predicate devices.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" in the machine learning sense. The "ground truth" related to the device's development is rooted in the proven design, performance, and safety of its predicate laser systems, which were themselves cleared based on their own data and clinical experience.

Summary

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Appendix E : Summary of Safety and Effectiveness Data

K022838

Company :	Fotona d.d.Stegne 7, 1210 LjubljanaSLOVENIA	NOV 2 5 2002
Contact Person :	Mojca Valjavec
Preparation Date :	08-12-02
Device Trade Names :	Fotona Dualis SV Er:YAG/KTP Laser System
Common Name :	Combination of Long Pulse Er:YAG and KTP Lasers
Classification Name :	Instrument, Surgical, Powered, Laser79-GEX21 CFR 878-48

II. Description

I. General Information

In case of the KTP laser through an optical fiber delivery system to a focusing . handpiece.
. In case of the Er: Y AG laser through articulated arm to a focusing handpiece.

Both lasers share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Er.YAG laser source or the KTP laser source. When the laser is first turned on the physician is able to select the desired wavelength via control panel.

III. Intended Use

The Fotona Dualis KTP laser is intended for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.

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The Fotona DualisSV Er:YAG laser is indicated for incision/excision, cutting, ablation, vaporization, and coagulation of soft and hard tissue in various surgical areas.

IV. Summary of Substantial Equivalence

Fotona believes that its Dualis" laser system is substantially equivalent to the Fotona DualisVP long pulse KTP laser system previously cleared for incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas, and to the Fotona Fidelis Er:YAG laser system previously cleared for incision/excision, cutting, ablation, vaporization, and coagulation of soft and hard tissue in various surgical areas.

They therefore have the same Intended Use as the Fotona Dualis " laser system.

The Dualiss Er: YAG/KTP laser system shares the same design features (wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing) as the predicate devices. The output characteristics are the same as those of the predicate devices.

The risk and benefits for the Dualis " laser system are comparable to the predicate devices when used for similar clinical applications.

It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of the Dualis" Er:YAG/KTP laser system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 2002

Fotona D. D. Mojca Valjavec QA/RA Manager Stegne 7, 1210 Ljubljana Slovenia

Re: K022838

Trade/Device Name: Fotona DUALIS® Er: YAG/KTP Laser System Regulation Number: 878.4810 Regulation Name: Powered, laser surgical instrument Regulatory Class: Class II Product Code: GEX Dated: August 20, 2002 Received: August 27, 2002

Dear Sir or Madam:

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

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Page 2 - Sir or Madam .

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. 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 Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

for Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Appendix F : Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Fotona Dualis88 Er:YAG/KTP Laser System and Accessories

Indications For Use:

KTP Laser (532 nm)

The treatment (hemostasis, color lightening, flattening, reduction of lesion size) of the vascular lesions (Angiomas, Hemangiomas, Telangiectasia)

Er:YAG Laser (2940 nm)

The Fotona Dualis Er:YAG laser is intended for surgical incision/excision, variorization and coaqulation of soft and hard tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, cartilage meniscus, mucous membrane, lymplı vessels and nodes, organs and glands.

Dermatology an Plastic Surgery Indications: Epidermal nevi, telangiectasias, spider veins, actinic sheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, decubitis ulcers, and skin resurfacing.

ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia Gynecology Indications: Herpes simplex, endomaterial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, and condiloma.

General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation.

Oral/Maxillofacial Indications: Oral and glossal lesions and gingivectorny

Ophtalmology Indications: Soft tissue surrounding the eye and orbit and anterior capsulotomy Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae and matrixectomy Dentistry indications: Caries removal, cavity preparation, enamel etching

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF MEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Miriam C. Provost
	(Division Sign-Off)
	Division of General, Restorative and Neurological Devices
Prescription Use (Per 21 CFR 801.109)	✓ 510(k) Number K022838	Over-The-Counter Use

Regulation Number and Section

§ 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.