The Fotona QX laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd: YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser 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 by articulated arm to a focusing handpiece. Both lasers are used in non-contact mode. Both laser wavelengths share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Nd: YAG head or the KTP Nd: YAG laser wavelength. When the laser is first turned on the physician is able to select the desired wavelength via control panel. The Fotona QX laser system consists of: a) A high voltage power supply, which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse. b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger. c) The microprocessor based controller, which regulates the functions of both lasers and allows parameter selection by the user. d) The Nd: YAG laser head. e) The frequency doubling crystal. g) The optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that specifically proves the Fotona QX Nd:YAG/KTP Laser System meets acceptance criteria. The document is a 510(k) premarket notification for the device, which aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with specific performance metrics and acceptance criteria.

Therefore, I cannot extract the requested information. The document focuses on:

General Information: Company, contact, device trade names, classification.
Device Description: Technical specifications of the laser system (Nd:YAG and KTP Nd:YAG wavelengths, energy delivery, spot sizes).
Intended Use: Clinical applications for both 1064 nm and 532 nm wavelengths (e.g., tattoo removal, pigmented lesions, hair removal, skin resurfacing, soft tissue ablation).
Summary of Substantial Equivalence: Comparison of the Fotona QX system's design features and intended uses to three predicate devices (Spectra-VRM, Medlite C6, and Palomar Q-YAG) to argue that it raises no new questions of safety or effectiveness.
FDA Correspondence: Letter from the FDA granting substantial equivalence.
Indications for Use Statement: Formal list of approved clinical applications.

The document lacks information on:

Acceptance Criteria Table: There is no table defining specific performance metrics and their acceptance thresholds.
Reported Device Performance: No clinical study results or performance data (e.g., efficacy rates, side effect profiles, a specific measure of "success" for tattoo removal or lesion treatment) are presented.
Sample Size and Data Provenance: No mention of test set sample sizes, country of origin, or whether any data was retrospective or prospective.
Number and Qualifications of Experts: No experts are mentioned as establishing ground truth for any test set.
Adjudication Method: Not applicable as no ground truth establishment is described.
MRMC Comparative Effectiveness Study: No such study is described, nor any effect size of AI assistance.
Standalone Performance: Not applicable as this is not an AI/algorithm-only device.
Type of Ground Truth: No ground truth (expert consensus, pathology, outcomes data) is mentioned as being used for any study.
Training Set Sample Size: Not applicable as this is not an AI/machine learning model where a training set would be used.
How Training Set Ground Truth Was Established: Not applicable.

This 510(k) submission is primarily a regulatory document demonstrating similarity to existing devices, not a scientific publication detailing a new clinical study.

Summary

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Appendix E : Summary of Safety and Effectiveness Data

I. General Information	FEB 1 6 2006	K053139
Company :	Fotona d.d.
	Stegne 7, 1210 Ljubljana
	SLOVENIA
Contact Person :	Stojan Trošt
Preparation Date :	11-04-05
Device Trade Names :	Fotona QX Nd:YAG/KTP Laser System
Common Name :	Combination of Q-switched Nd:YAG and KTP Nd:YAG Lasers
Classification Name :	Instrument, Surgical, Powered, Laser
	79-GEX
	21 CFR 878-48

II. Description

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

The Fotona QX laser system consists of:

a) A high voltage power supply, which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.

b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.

c) The microprocessor based controller, which regulates the functions of both lasers and allows parameter selection by the user.

d) The Nd: YAG laser head.

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e) The frequency doubling crystal.

g) The optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.

III. Intended Use

The Nd:YAG (1064 nm) laser is capable of delivering up to 1.0 J of laser energy. Its The Nd. ITAS (100+ mir) tabel 16 capaces on or sizes available range from 2 to 8 mm. This nominal pulsewithin is 1 7 minoooooonaed for incision/excision, ablation, vaporization of soft tissue in general dermatology, removal of dark ink (black, blue and brown) tattoos, Son lissue in general definatorial or lightening of unwanted hair, treatment of Common Nevi.

The frequency doubled Nd: YAG (532 nm) KTP laser delivers up to 0.5J of laser energy in 4-9 nanosecond pulses. Spot sizes available range from 2 to 7 mm. This laser wavelength is intended to be used for incision/excision, ablation, vaporization of soft wavelength is intended to be assureal of light ink (red, tan, purple, and orange) tatoos, removal of pigmented lesions, removal of vascular lesions, treatment of Lentigines, treatment of Cafe-Au-Lait, treatment of Common Nevi, treatment of Seborrheic Kearotoses, and treatment of Post Inflammatory Hyperpigmentation.

IV. Summary of Substantial Equivalence

Fotona believes that its Fotona QX laser system is substantially equivalent to the

a) Spectra -VRM Q-switched Nd: YAG Laser System (K000317) previously cleared for:

Incision, excision, ablation, vaporization of soft tissue for general dermatology
532 nm wavelength:
- removal of light ink (red, tan, purple, and orange) tatoos,
- removal of pigmented lesions, removal of vascular lesions,
- treatment of Lentigines, treatment of Cafe-Au-Lait,
- treatment of Common Nevi, ।
- treatment of Seborrheic Kearotoses, ।
- treatment of Post Inflammatory Hyperpigmentation. ।
1064 nm wavelength: =
- removal of dark ink (black, blue and brown) tattoos, -
- treatment of Nevus of Ota, -
- removal or lightening of unwanted hair, -
- treatment of Common Nevi. -

b) Medlite C6 Q-Switched Nd:YAG Laser (K 014234) previously cleared for incision, excision, ablation, vaporization of soft tissue for general dermatology, Tatoo removal, treatment of Vascular Lesions and treatment of Pigmented Lesions.

c) Palomar Q-YAG Nd:YAG Laser System (K023967) previously cleared for skin resurfacing with or without adjuvant preparation at the 1064 nm wavelength.

510(k) Submission: Fotona QX Nd: YAG/KTP Laser System

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

The Fotona QX laser system shares the same design features (wavelength, active medium, cooling system, power supply, beam deliveries, controls, housing) as the medicate devices. The output characteristics are the same as those of the predicate devices.

The risk and benefits for the Fotona QX 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 Fotona QX Nd: YAG/KTP laser system.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines extending from its head, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

FEB 1 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stojan Trost Manager Quality Assurance & Regulatory Affairs Fotona D.D. Stegne 7 1210 Ljubljana SLOVENIA

Re: K053139

Trade/Device Name: Fotona QX Nd: Y AG/KTP Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: 21 CFR 078.1070
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 5, 2006 Received: January 9, 2006

Dear Mr. Trost:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) premained is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosule) it regars and the Medical Device Amendments, or to commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that Go not require appen o the general controls provisions of the Act. The r ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the line, 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 it may of Subject to Saon additional Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oous of eneming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuance or a cassince complies with other requirements of the Act that I DA has made a decertimation administered by other Federal agencies. You must of any I cocraf statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Kahan

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (2001) 100 (2006) (2006) 1985 (2006) 1985-1994 (21 CFR 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the support of any and consumeration of your device to a legal This letter will allow you to begin marketing your avvalence of your device to a legally
premarket notification. The FDA finding of substantial end the permits vour premarket notification. The FDA Inding of basisance of the results 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
rs the latest of the support of 115 - All and assesses the regulation entit If you desire specific advice for your device on our an Also, please note the regulation entitled.
contact the Office of Compliance at (240) 276-0115. Also, please note the r contact the Office of Compliance at (240) 270 - 121 - 121 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 - 1 - 1 - 1 - 1 - 1 - 1 - 1 "Misbranding by reference to prematici notification (c) * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * other general information on your responsionities and its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance at to vote a
(301) 443-6597 or at its Internet address http://www.fda.cov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Acting 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): K053139

Device Name: Fotona QX Nd:YAG/KTP Laser System

Indications For Use:

1. Incision, excision, ablation, vaporization of soft tissue for general dermatology.
1. 532 nm wavelength:
- removal of light ink (red, tan, purple, and orange) tatoos, "
- removal of pigmented lesions, removal of vascular lesions,
- treatment of Lentigines, treatment of Cafe-Au-Lait,
- treatment of Common Nevi,
- treatment of Seborrheic Kearotoses,
- treatment of Post Inflammatory Hyperpigmentation.
1. 1064 nm wavelength:
- removal of dark ink (black, blue and brown) tattoos, -
- treatment of Nevus of Ota, -
- removal or lightening of unwanted hair, -
- treatment of Common Nevi. -
- skin resurfacing with or without adjuvant preparation --

(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)

ØR
(Division Sig
Division of General, Restorative,
and Neurolog Devices

510(k) Number

Over-The-Counter Use

510(k) Submission: Fotona QX Nd:YAG/KTP 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.