The Fotona DUALIS'" Plus Nd: YAG laser system is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology:

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 Fotona DUALIS 8 Plus system is based on the Nd: Y AG laser technology. Within the system, an optical cavity contains the Nd: Y AG 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 beams 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 text is a 510(k) premarket notification for the Fotona DUALISXP Plus Nd:YAG Laser System. It includes a summary of safety and effectiveness data and a substantial equivalence review. However, it does not contain information regarding detailed acceptance criteria, a specific study proving the device meets those criteria, or the specific performance metrics requested.

The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Altus Medical Aesthetic Nd:YAG Laser) by comparing design characteristics, intended use, and risk/benefit profiles. It does not present a de novo study with acceptance criteria and a detailed analysis of the device's performance against them.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text.

Here is what can be inferred and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated in the document. The basis for acceptance is "substantial equivalence" to a predicate device, implying that its characteristics and performance are comparable.
Reported Device Performance: Not detailed in terms of specific quantitative metrics (e.g., hair reduction percentage, lesion coagulation rate, incision depth/precision) that would typically be associated with performance studies against acceptance criteria. The document only states that the device is "substantially equivalent" and its "risk and benefits... are comparable to the predicate device."

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

Not applicable/Not provided. No "test set" in the context of a performance study against specific acceptance criteria is described. The submission is a substantial equivalence claim, not a de novo clinical trial demonstrating performance.

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

Not applicable/Not provided. No independent expert review for a test set's ground truth is mentioned. The FDA's review process determines substantial equivalence.

4. Adjudication method for the test set:

Not applicable/Not provided.

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 and aesthetic applications, not an AI diagnostic or assistance tool that would typically involve human readers.

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

Not applicable/Not provided. This is a physical laser device, not an algorithm.

7. The type of ground truth used:

Not applicable/Not provided. If any "ground truth" concept applies, it would be historical clinical experience and regulatory acceptance of the predicate device's performance and safety profile, rather than a specific ground truth for a new performance study.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of a "training set" as this is a hardware device submission, not a machine learning model.

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

Not applicable/Not provided.

In summary, the provided document is a regulatory submission for substantial equivalence based on a comparison to an existing device, rather than a detailed report of a performance study against specific acceptance criteria.

Summary

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839 Appendix E:

1/2 Summary of Safety and Effectiveness Data

I. General Information

NOV 2 5 2002

Company :	Fotona d.d.Stegne 7, 1210 LjubljanaSLOVENIA
Contact Person :	Mojca Valjavec
Preparation Date :	08-05-01
Device Trade Names :	Fotona DUALISXP Plus Nd:YAG Laser Systern
Common Name :	Nd:YAG Pulsed Surgical Laser System
Classification Name :	Instrument, Surgical, Powered, Laser79-GEX21 CFR 878-48

II. Description

II. Intended Use

The Fotona DUALIS* Plus Nd: YAG laser system 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 system 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 Fotona DUALIS'x Plus laser shares the same general indications for use, and therefore is substantially equivalent to the currently marketed Altus Medical Aesthetic Nd:YAG Laser.

510(k) Submission: The Fotona DUALISNº Plus Nd:YAG Laser System

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K022839 2/2 Technologically, the predicate device has similar characteristics to the DUALISM Plus laser. Both 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.

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

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

Both 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*P Plus laser system are comparable to the predicate device 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* Plus laser system.

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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 & Human Services. The logo consists of a stylized caduceus symbol, which features three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 200 Corporate Boulevard ockville MD 20850

NOV 2 5 2002

Fotona D. D. Mojca Valjavec OA/RA Manager . Stegne7, 1210 Ljubljana Slovenia

Re: K022839

Trade/Device Name: Fotona DUALIS Plus Nd: YAG Laser System Regulation Number: 878.4810 Regulation Name: Instrument, powered surgical laser 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 yours,

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

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K (222 3 9

Device Name:

Fotona DUALISNY Plus Nd: YAG Laser System 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

iriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number: KC22839

510(k) Submission: The Fotona DUALISM Plus Nd:YAG Laser System

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.