The Fotona F-22 Handpiece is intended for:
. In fractionated mode:
Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;
: ` In non-fractionated mode:
General Surgery Indications: Surgical incision, 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 is necessary;

The Fotona FS-01 Handpiece is intended for:
Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece.

Device Description

The F-22 Handpiece and FS-01 Handpiece each attach to the Dynamis Er: Y AG/Nd: YAG Laser Systems. The Fotona Dynamis Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The F-22 handpiece and FS-01 handpiece are designed to be used with the Er:YAG (2940 nm) laser wavelength only. The laser system console consists of a flashlamp pumped Er: YAG laser source, power supply, water colling unit, electronics, and a footswitch. Electrical power is supplied to the console by the facility's power source. A red diode aiming beam (650 nm) is combined with the therapeutic Er:YAG laser beam. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er:YAG laser). Fotona's power supply and electronics, integrated into the laser system, allows control of the laser energy and the laser pulse duration. The user activates laser emission by means of a footswitch.

AI/ML Overview

This document describes the regulatory submission for the Fotona F-22 Laser Handpiece and Fotona FS-01 Laser Handpiece. It does not contain information about the acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a clinical trial with predefined performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices. This means that the new devices are considered safe and effective because they are similar in design, technological characteristics, and intended use to devices already cleared by the FDA.

Therefore, many of the requested categories of information cannot be directly extracted from the provided text in the traditional way an AI model's performance study might be described. However, I will address what information is available and highlight what is not.

Acceptance Criteria and Device Performance

There are no explicit "acceptance criteria" presented in the document in the format of performance thresholds (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices, which implies that the new handpieces perform comparably to established devices already deemed safe and effective.

The "reported device performance" is primarily characterized by its technological specifications matching or being similar to the predicate devices, and a general statement about a clinical and histological study.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Technological Characteristics & Claimed Effect)
Technological Equivalence: Output wavelength, laser media, aiming beam, output mode, pulse energy range, pulse width range, repetition rate, power, beam delivery, user interface.	Wavelength: 2940 nm (Er:YAG) Laser Media: Flashlamp pumped solid-state rod Aiming Beam: 650 nm Output Mode: Pulsed Pulse Energy: 30 - 3000 mJ Pulsewidth: 100 - 300 us Repetition Rate: Up to 50 Hz Power: Up to 20 W Beam Delivery: Articulated arm User Interface: Push button control Handpieces: FS-01, F22
Indications for Use Equivalence: Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece; General Surgery Indications (F-22 in non-fractionated mode)	Intended for: - Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece. - (F-22 only, non-fractionated) General Surgery Indications: Surgical incision, vaporization and coagulation of soft tissue.
Safety and Standards Compliance: Adherence to relevant IEC and CFR standards.	Fotona F-22 and FS-01 handpieces are designed, tested, and will be manufactured in accordance with standards including 21 CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, EN 62304, ISO 17664.

Study Details (Based on the provided text)

Sample size used for the test set and the data provenance:
- The document mentions a "clinical and histological study" but does not specify the sample size for human subjects or histology samples.
- There is no information about data provenance (e.g., country of origin, retrospective/prospective).
- A "test set" in the context of an AI model's performance is not directly applicable here. This is a medical device submission, not specifically an AI model submission. The "testing" refers to device validation and verification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The "ground truth" for a laser device would typically relate to the biological effect (e.g., tissue ablation, resurfacing), which is assessed by medical professionals. The document mentions a "clinical and histological study" to demonstrate benefits, implying expert assessment, but gives no specifics on the number or qualifications of clinicians/pathologists.
Adjudication method for the test set:
- This information is not provided.
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 MRMC comparative effectiveness study is mentioned. This is a laser handpiece, not an AI diagnostic or assistive tool, so such a study design is unlikely to be performed for this device type.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This is a physical laser handpiece, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document states "A clinical and histological study... has been performed to demonstrate the benefits of dermatological procedures requiring resurfacing and ablation of soft tissue with the fractionated handpieces."
- This suggests that histology (pathology) and clinical observation/outcomes were used to assess the "benefits."
The sample size for the training set:
- This question is not applicable as this is a medical device, not an AI model requiring a "training set."
How the ground truth for the training set was established:
- This question is not applicable as this is a medical device, not an AI model requiring a "training set."

Summary

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5. 510(k) Summary

1. SUBMITTER'S INFORMATION

Name:

Fotona d.d.

Address:

Stegne 7 1000 Ljubljana, Slovenia Phone: +386 15009100 Fax: + 386 5009 200

Contact Person:

Stojan Trošt, QA&RA Manager Phone: + 386 1 5009 299 E-mail: stojan.trost@fotona.com

Date Prepared: July 8, 2014

2. DEVICE INFORMATION

Trade Name:	Fotona F-22 Laser Handpiece (F-Runner),
	Fotona FS-01 Laser Handpiece

Common Name: Er:YAG Surgical Laser

Classification Name: Powered laser surgical instrument with microbeam\fractional output

Product Code: ONG, GEX

3. PREDICATE DEVICES

Fotona Dynamis Er:YAG/Nd:YAG Laser System Family (K101306),

JOULE Multi-Platform System (K101916),

Dermablate Effect, ASCLEPION Laser Technologies GmbH (K081541)

JUL 1 1 2014 K1328DL

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4. DEVICE DESCRIPTION

4. INTENDED USE

The Fotona F-22 Handpiece is intended for:

In fractionated mode: -
- Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;
In non-fractionated mode: ।
- General Surgery Indications: Surgical incision, 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 is necessary;

The Fotona FS-01 Handpiece is intended for:

Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece.

5. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The F-22 Handpiece and FS-01 Handpiece accessories to Fotona Dynamis family have the same technological and design characteristics (design, chemical composition, energy source: wavelength, active medium, cooling system, power supply, beam delivery, controls, housine) as the previously cleared devices. The output characteristics are for the intended use the same as those of the predicate devices. The risk and benefits for the F-22 Handpiece and FS-01 Handpiece accessories to Fotona Dynamis Fotona Dynamis Laser System family are identical to the predicate devices when used for similar clinical applications.

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Er: YAG2940 nm	Sciton JOULE Multi-Platform System Er:YAG(K101916)	Fotona Dynamis LaserSystem Family(K101306)	Dermablate Effect,ASCLEPION LaserTechnologies GmbH(K081541)	Fotona Dynamis LaserSystem Family(new submission)
Wavelength	2940 mm	2940 nm	2940 nm	2940 nm
Laser media	Flashlamp pumped solidstaterod	Flashlamp pumped solidstaterod	Flashlamp pumped solidstaterod	Flashlamp pumped solidstaterod
Aiming beam	630 - 680 nm	650 nm	650 nm	650 nm
Output mode	Pulsed	Pulsed	Pulsed	Pulsed
Pulse energy	20-8000 mJ	30 - 3000 mJ	Up to 1500 mJ	30 - 3000 mJ
Pulsewidth	100 - 500 us	100 - 1500 us	400 us	100 - 300 us
Repetition rate	Up to 40 Hz	up to 50 Hz	Up to 20 Hz	up 10 50 Hz
Power	40W	up to 20 W	Up to 12W	up to 20 W
Beam Delivery	Articulated arm	Articulated arm	Articulated arm	Articulated arm
User interface	LCD Touchscreen	Push button control	LCD Touchscreen	Push button control
Handpieces	ProFractional	R08	Asclepion DermablateEffect with MicroSpothandpiece	FS-01F22

Figurl : Comparison table of the technical characteristics for the predicate laser system and for the host laser system for the newly submitted handpieces

6. STATEMENT OF SUBSTANTIAL EQUIVALENCE

The F-22 Handpiece and FS-01 Handpiece are substantially equivalent in terms of indications for use and technology based on technical characteristics to the following predicate devices when used according to its intended use: Fotona Dynamis Er.YAG/Nd:YAG Laser System Family (K101306) and JOULE Multi-Platform System with Profractional handpiece (K101916), Dermablate Effect, ASCLEPION Laser Technologies GmbH (K081541).

7. TESTING

Clinical testing:

A clinical and histological study with the Fotona Dynamis SP laser system (a model from The Fotona Dynamis Er:YAG/Nd:YAG Laser System Family) using FS-01 stamping fractionated handpiece and F22 scanning fractionated handpiece has been performed to demonstrate the benefits of dermatological procedures requiring resurfacing and ablation of soft tissue with the fractionated handpieces.

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Non-clinical performance testing

Fotona F-22 Laser Handpiece (F-Runner) and Fotona FS-01 Laser Handpieces are designed. tested and will be manufactured in accordance with both mandatory and voluntary standards including:

21 CFR 1040.10 Performance Standards for Light Emitting Products, Laser products .
21 CFR 1040.11 Performance Standards for Light Emitting Products, Specific . purpose laser products
IEC 60601-1 Ed.3.0: 2005 + Corr 1. 2006 + Corr 2. 2007 Medical electrical . equipment. Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Ed.3.0: 2007 Medical electrical equipment. Part 1-2: General . requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility-Requirements and tests
IEC 60601-1-4 Ed. 1.1: 1996 + A1:1999 Medical electrical equipment. Part 1-4: . Collateral standard: Programmable electric medical systems.
IEC 60601-1-6 Ed.2.0:2007 Medical electrical equipment: Part 1-6: General . requirements for basic safety and essential performance - Collateral standard: Usability
. IEC 60601-2-22 Ed. 2.0: 1996 - Medical electrical equipment, Part 2: Particular requirements for safety diagnostic and therapeutic laser equipment.
IEC 60825-1 Ed. 2.0 /2007 Safety of laser products. Part 1: Equipment classification . and requirements.
EN 62304: 2006 Medical device Software software life-cycle process .
ISO 17664:2004 Sterilization of medical devices Information to be provided by the . manufacturer for the processing of resterilizable medical devices

Laboratory testing was conducted to validate and verify that the proposed handpieces: Fotona F-22 Laser Handpiece (F-Runner) and Fotona FS-01 Laser Handpieces met all design specifications and was substantially equivalent to the predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings and body. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2014

Fotona d.d. Stojan Trost Quality Assurance & Regulatory Affairs Manager Stegne 7, 1000 Ljubljana, Slovenia

Re: K132806 Trade/Device Name: Fotona F-22 Laser Hand piece (F-Runner), Fotona FS-01 Laser Handpiece Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONG, GEX Dated: June 12, 2014 Received: June 16, 2014

Dear Stojan Trost:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Stojan Trost

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No, 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K132806

Device Name

Fotona F-22 (f-runner), Fotona FS-0) laser handpieces

Indications for Use (Describe)

The Fotona F-22 Handpiece is intended for:

. In fractionated mode:

Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;

: ` In non-fractionated mode:

General Surgery Indications: Surgical incision, 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 is necessary;

The Fotona FS-01 Handpiece is intended for:

Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden -S 2014.07.10 16:45:17 -04'00'

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This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per resoonse, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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.