The Fotona Dualis KTP (532 nm) Laser System and Accessories 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.

Dermatology :

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

Device Description

The Fotona Dualis KTP (532 nm) system is based on Nd:YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.

The Dualis KTP system is designed with 3 major sub-systems:

a) An optical delivery system, interfacing the energy from the laser to the patient via an optical fiber arm and a focusing handpiece.

b) An electronic power supply and interface circuitry.

c) An optical chamber containing laser rod and laser cavity optics.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Fotona Dualis KTP (532 nm) Laser System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a novel device. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, expert ground truth establishment, and comparative effectiveness studies is not available in this type of regulatory submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria:
- The primary "acceptance criteria" here is meeting the regulatory requirements for substantial equivalence to predicate devices under 21 CFR 878.4810 for "Instrument, Surgical, Powered, Laser." This means demonstrating that the device is as safe and effective as existing legally marketed devices.
- Specific performance characteristics are implicitly compared to predicate devices, but explicit quantitative acceptance criteria with pass/fail thresholds are not detailed in this summary. Instead, the claim is that the output characteristics are "very similar" and risks/benefits are "comparable."
Reported Device Performance:
- The document states that the Fotona Dualis KTP (532 nm) laser output characteristics are very similar to those of the predicate devices.
- It also states that the risk and benefits for the Fotona Dualis KTP (532 nm) are comparable to the predicate devices when used for similar clinical applications.
- No numerical performance metrics (e.g., specific power output ranges, pulse durations, or ablation rates with associated tolerance limits) are provided in this summary as "reported device performance."

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance
Substantial equivalence to predicate devices (Coherent VersaPulse, Laserscope Lyra, and other KTP lasers) in terms of:
- Intended Use	Intended use is identical: incision, ablation, vaporization, coagulation, and hemostasis of vascular lesions and soft tissue in various surgical areas (skin, cutaneous, subcutaneous, striated/smooth muscle, cartilage, mucous membrane, lymph vessels/nodes, organs, glands). Specific dermatological use for vascular lesions (Angiomas, Hemangiomas, Telangiectasia) also listed.
- Technological Characteristics (e.g., laser type, wavelength, delivery system, control system)	Identical characteristics: Nd:YAG laser rod generating 532 nm wavelength; delivered via optical fiber and focusing handpiece; microprocessor controlled; Class I aiming beams; internal closed-loop water-air heat exchanger.
- Output Characteristics	"Very similar to those of the predicate devices." (No specific numerical values provided in this document).
- Safety and Effectiveness (risks and benefits)	"Comparable to the predicate devices when used for similar clinical applications." "No new questions of Safety or Effectiveness raised."

2. Sample size used for the test set and the data provenance:

Not Applicable / Not Provided. This type of 510(k) summary does not typically include clinical test set data from efficacy studies, as the primary path to clearance is substantial equivalence to existing devices, often relying on technological comparisons and bench testing rather than new clinical trials. No clinical "test set" with patient data is mentioned in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable / Not Provided. As no new clinical test set is described, there's no mention of experts establishing a ground truth for such a set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable / Not Provided. No test set or adjudication method 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 / Not Provided. This device is a laser system for surgical procedures, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable / Not Provided. This is a physical surgical laser device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable / Not Provided. No new clinical ground truth establishment is described in this substantial equivalence summary. The "ground truth" for the clearance is effectively the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not Applicable / Not Provided. This is a hardware medical device, not a machine learning algorithm that requires a "training set" in the computational sense.

9. How the ground truth for the training set was established:

Not Applicable / Not Provided. As above, the concept of a training set and its ground truth is not applicable to this 510(k) submission for a surgical laser system.

Summary

{0}------------------------------------------------

Summary of Safety and Effectiveness Data

I. General Information	DEC 2 7 2001
Company :	Fotona d.d.Stegne 7, 1210 Ljubljana, Slovenia
Contact Person :	Mojca Valjavec
Preparation Date :	06-11-01
Device Trade Name :	Fotona Dualis KTP (532 nm) Laser System andAccessories
Common Name :	Frequency Doubled Nd:YAG Pulsed Surgical LaserSystem
Classification Name :	Instrument, Surgical, Powered, Laser79-GEX21 CFR 878-4810

II. Description

The Dualis KTP system is designed with 3 major sub-systems:

a) An optical delivery system, interfacing the energy from the laser to the patient via an optical fiber arm and a focusing handpiece.

b) An electronic power supply and interface circuitry.

c) An optical chamber containing laser rod and laser cavity optics.

II. Intended Use

The Fotona Dualis KTP (532 nm) laser system is indicated 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.

{1}------------------------------------------------

III. Summary of Substantial Equivalence

Fotona believes that its Dualis KTP (532 nm) system is substantially equivalent to the Coherent VersaPulse laser system, Laserscope Lyra laser system, and to other KTP (532 nm) lasers previously cleared for similar clinical applications.

All lasers are cleared for surgical 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.

Technologically, the predicate devices have identical characteristics to the Dualis KTP (532 nm) laser, all three comprising an electronic control module and a flashlamp pumped Nd: YAG laser rod generating light at a wavelength of 532 um, which is subsequently delivered to the patient via an optical fiber and a focusing handpiece.

The Dualis KTP (532 nm) laser output characteristics are very similar to those of the predicate devices.

All lasers are microprocessor controlled devices.

All lasers utilize class I aiming beams which pose no hazard to the user.

All systems utilize an internal closed loop water-air heat exchanger circuit for optimal thermal control of the laser cavity.

The risk and benefits for the Fotona Dualis KTP (532 nm) 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 this device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 2001

Mojca Valjavec Fotona D. D. Stegne 7 1210 Ljubljana Slovenia

Re: K011939 Trade Name: Fotona Dualis Regulation Number: 878.4810 Regulation Name: Instrument, Surgical, Powered, Laser Regulatory Class: II Product Code: GEX Dated: October 11, 2001 Received: October 11, 2001

Dear Ms. Valjavec:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

{3}------------------------------------------------

Page 2 – Ms. Mojca Valjavec

This letter will allow you to begin marketing your device as described in your Section I has letter will anon you to of 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 If you desire specific ad rise 10.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion orner of Companies and advice, 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) 6382041 or (301) 4436597 or at its Internet address HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

StipL Clurdu

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

Enclosure

{4}------------------------------------------------

APPENDIX F

Page 1 of 1

INDICATIONS FOR USE STATEMENT

K 011939 510(k) Number (if known):_

Device Name:

FOTONA DUALIS KTP (532 nm) LASER SYSTEM AND ACCESSORIES

Indications For Use:

Dermatology :

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use > (Per 21 CFR 801.109)

Over-The-Counter Use

Hye Purdn
Division Sign Off

(Division Sign-Off) Division of General, Restorati and Neurological Devices

510(k) Number_ KOU 939

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.