To effect stable long-term, or permanent, hair reduction in skin types I VI through . selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a longterm stable reduction in the number of hairs regrowing after a treatment regimen.
For removal of unwanted hair. ◆
For coagulation and hemostasis of vascular lesions.
For incision/excision of soft body tissue in dermatology .
For soft tissue general surgery applications skin incision, tissue dissection; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation

Device Description

The family of Fotona Dualis systems is based on the Nd: YAG laser technology. Within the systems, 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 therapeutic and aiming bearns are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.

AI/ML Overview

The provided document is a 510(k) summary for the Fotona DualisXP, DualisVP, and Twinlight Nd:YAG Laser Systems. It establishes substantial equivalence to previously marketed devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

The document focuses on:

General Information: Device trade names, common name, classification.
Description: How the laser system works (Nd:YAG technology, flashlamps, optical cavity, fiber delivery, aiming beam).
Intended Use: Surgical and aesthetic applications, including permanent hair reduction in Fitzpatrick skin types I-VI, removal of unwanted hair, coagulation/hemostasis of vascular lesions, and soft tissue incision/excision.
Summary of Substantial Equivalence: Comparing the described device to predicate devices (Laserscope Lyra K010834 and Altus Medical Aesthetic Nd:YAG Laser K003202) based on technological characteristics (e.g., flashlamp pumped Nd:YAG, 1064 nm wavelength, fiber delivery, Class I aiming beams, microprocessor control, internal cooling). The core argument is that the risks and benefits are comparable.
FDA Clearance Letter: Confirming the substantial equivalence determination for the stated indications for use.
Indications for Use Statement: A formal list of approved uses.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text. This document is a regulatory submission demonstrating equivalence, not a clinical study report with performance data against acceptance criteria.

Based on the provided text, the following information is available or can be inferred:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Technological Equivalence to Predicate Devices:
Wavelength: 1064 nm	1064 nm
Pumping mechanism: Flashlamp pumped	Flashlamp pumped
Delivery system: Optical fiber and focusing handpiece	Optical fiber delivery system and focusing handpiece
Aiming beam classification: Class 1	Class I aiming beams
Control: Microprocessor controlled	Microprocessor controlled devices
Thermal control: Internal closed loop water-air heat exchanger	Internal closed loop water-air heat exchanger circuit
Clinical Equivalence to Predicate Devices:
Ability to perform indicated surgical and aesthetic applications	Indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue Indicated for stable long-term or permanent hair reduction in Fitzpatrick skin types I-VI.
Risks and benefits comparable to predicate devices	Risks and benefits for the DUALIS family are comparable to the predicate devices when used for similar clinical applications.
No new questions of Safety or Effectiveness	Believed that there are no new questions of Safety or Effectiveness raised by the introduction of the DUALIS family.

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 / Not provided. This document does not describe a clinical study with a test set of data. It is a substantial equivalence submission.

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 / Not provided. No test set or ground truth establishment mentioned.

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

Not applicable / Not provided. No test set or ground truth establishment mentioned.

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

No. This is a laser device, not an AI or imaging diagnostic device.

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

No. This is a laser device, not an AI or algorithm-based device.

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

Not applicable / Not provided. The "ground truth" in this context is the performance and safety profile of the predicate devices against which the new device is compared for equivalence. There are no specific "ground truth" measurements for the Fotona DUALIS devices presented in this document.

8. The sample size for the training set

Not applicable / Not provided. This is not an AI/machine learning device.

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

Not applicable / Not provided. This is not an AI/machine learning device.

Summary

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

DEC 0 6 2001 ppendix E:

Summary of Safety and Effectiveness Data

I. General Information
K013047

Company :	Fotona d.d.Stegne 7, 1210 LjubljanaSLOVENIA
Contact Person :	Mojca Valjavec
Preparation Date :	05-09-01
Device Trade Names :	Fotona DualisXP Nd:YAG Laser SystemFotona DualisVP Nd:YAG Laser SystemFotona Twinlight Nd:YAG Laser System
Common Name :	Nd:YAG Pulsed Surgical Laser System
Classification Name :	Instrument, Surgical, Powered, Laser79-GEX21 CFR 878-48

II. Description

II. Intended Use

The family of Fotona DUALIS Nd: YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. In addition, the family is indicated to effect stable long-term, or permanent hair reduction in Fitzpatrick skin types I - VI through selective targeting of melanin in hair follicles (where permanent hair reduction is defined as a long-term stable reduction in number of hairs regrowing after a treatment regimen).

III. Summary of Substantial Equivalence

The family of Fotona DUALIS lasers shares the same general indications for use, and therefore is substantially equivalent to the currently marketed Laserscope Lyra (K010834) and to Altus Medical Aesthetic Nd: YAG Laser (K003202).

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

Technologically, the predicate devices have similar characteristics to the DUALIS lasers. All systems comprising a flashlamp pumped Nd. YAG laser rod generating light at a wavelength of 1064 nm, which is subsequently delivered to the patient via an optical fiber delivery system and focusing handpiece.

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

All systems are microprocessor controlled devices. The microprocessor control regulates normal operation, permits parameter selection and avoids hazard incidence.

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 DUALIS family 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 family.

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

Image /page/2/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature. The logo is simple and conveys a sense of national authority and health-related services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 6 2001

Mojca Valjavec, Dipl. Eng. Laser Division Fotona d.d. Stegne 7 1210 Ljubljana Slovenia

Re: K013047

Trade Name: Fotona DUALIS Nd: YAG Laser System Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: September 6, 2001 Received: September 10, 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 May 20, 1970, and charter 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, (Trefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer and act include requirements for annual registration, listing of devices, Controls provisions or are ice, 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 If your device 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 or any 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 510(k) I mis letter will and w yours over finding of substantial equivalence of your device to a legally premarket notifications of 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 and 11 you desire specific advise for in vitro diagnostic devices), please contact the Office of additionally 21 Cl 1 1 1 1 1 1 1 4 659. Additionally, for questions on the promotion and advertising of Compination at (301) 69 to 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 Other general mistmational 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 yours,

Susan Walker

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 I of 1

INDICATIONS FOR USE STATEMENT

KO13047 510(k) Number (if known):

Device Name:

Family of Fotona DUALIS Nd:YAG Laser Systems and Accessories

Indications For Use:

To effect stable long-term, or permanent, hair reduction in skin types I VI through . selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a longterm stable reduction in the number of hairs regrowing after a treatment regimen.
For removal of unwanted hair. ◆
For coagulation and hemostasis of vascular lesions.
For incision/excision of soft body tissue in dermatology .
For soft tissue general surgery applications skin incision, tissue dissection; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation

(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

Susan Walker, m

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

510(k) Number_KO13047

510(k) Submission: Family of Fotona DUALIS Nd: YAG Lasers

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.