Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing;
ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
Oral/Maxillofacial Indications: Oral and glossal lesions;
Ophtalmology Indications: Soft tissue surrounding the eye;
Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;
General Surgery Indications: Surgical incision/excision, 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;
Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;

Dynamis Nd: YAG laser (1064 nm wavelength):

Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy;
Laser assisted lipolysis;
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin;
Treatment of wrinkles;
Treatment of mild to moderate inflammatory acne vulgaris;
Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins:
Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.

Device Description

The Fotona Dynamis Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er: YAG and Nd: YAG crystals. A red diode aiming beam (650 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beans are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical manual or scanner hand piece (in the case of the Nd: YAG laser). Optionally, the Nd: YAG therapeutic and aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end. Fotona's power supply Variable Square Pulse (VSP) Technology, 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.

The Fotona Dynamis Laser System Family is designed to operate in five configurations (models):

XS Dynamis: Single Er:YAG laser system
XP Dynamis: Single Nd:YAG laser system
SP Dynamis: Combined Er: YAG/Nd: YAG laser system
XP Spectro: Single Nd:YAG laser system, with lower average output power of Nd:YAG laser and smaller housing
SP Spectro: Combined Er:YAG/Nd:YAG laser system, with lower average output power of -Nd:YAG laser and unchanged specifications of Er:YAG laser, and smaller housing.

AI/ML Overview

This document is a 510(k) summary for the Fotona Dynamis Er:YAG/Nd:YAG Laser System Family, aimed at demonstrating substantial equivalence to previously cleared devices. It does not contain information about a study proving the device meets a set of acceptance criteria in the way a clinical trial or performance study for a diagnostic AI device would.

Instead, the submission relies on demonstrating technological equivalence to existing devices. This means that the device's characteristics and intended uses are so similar to already approved predicate devices that it is considered equally safe and effective.

Therefore, many of the requested categories for a study proving acceptance criteria are not applicable to this type of submission. However, I can extract the relevant information regarding the comparative aspects presented.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are not explicit performance metrics for a novel technology but rather the demonstration that the new device's technical specifications and intended uses fall within the established parameters of predicate devices. The "reported device performance" is essentially a comparison of these specifications.

Characteristic	Acceptance Criteria (Predicate Devices - Range/Value)	Reported Device Performance (Fotona Dynamis Family)
Nd:YAG Laser (1064 nm)
Wavelength	1064 nm	1064 nm
Laser media	Flashlamp pumped solid state rod	Flashlamp pumped solid state rod
Aiming beam	650 nm	650 nm
Output mode	Pulsed	Pulsed
Pulse energy	up to 120 J (K050293), up to 10 J (K090126)	up to 50 J
Pulsewidth	1 – 200 ms (K050293), 0.1-50 ms (K090126)	0.1 - 50 msec
Repetition rate	up to 12 Hz (K050293), up to 64 Hz (K090126)	up to 50 Hz
Power	up to 120 W (K050293), up to 30 W (K090126)	up to 80 W
Beam delivery	Fiber	Fiber
User interface	Push button control	Push button control
Er:YAG Laser (2940 nm)
Wavelength	2940 nm	2940 nm
Laser media	Flashlamp pumped solid state rod	Flashlamp pumped solid state rod
Aiming beam	650 nm	650 nm
Output mode	Pulsed	Pulsed
Pulse energy	25 - 1500 mJ (K093162), 40 - 1000 mJ (K021548)	30 - 1500 mJ
Pulsewidth	50 – 1000 μs (K093162), 75 - 950 μs (K021548)	100 – 1500 μs
Repetition rate	up to 50 Hz (K093162), up to 30 Hz (K021548)	up to 50 Hz
Power	up to 20 W (K093162), up to 15 W (K021548)	up to 20 W
Beam Delivery	Articulated arm	Articulated arm
User interface	Touch screen and push button control (K093162), Push button control (K021548)	Push button control

Summary of Equivalence: The document states, "The Fotona Dynamis Er:YAG/Nd:YAG Laser System Family is substantially equivalent to Fotona Dualis SP Nd:YAG/Er:YAG Laser System (K021548), Fotona Fidelis III Er:YAG/Nd: YAG Laser System (K093162), Fotona XP Nd:YAG Laser System (K090126) and Fotona XP Plus Nd:YAG Family of Laser Systems (K050293). The Fotona Dynamis Er: YAG/Nd:YAG Laser System Family is substantially equivalent in terms of indications for use and technology based on technical characteristics."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as there was no "test set" in the context of a performance study for a novel diagnostic or AI device. The submission relies on a comparison of technical specifications to predicate devices.

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)

This information is not applicable as there was no "test set" and no ground truth establishment by experts for performance evaluation.

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

This information is not applicable as there was no "test set" requiring adjudication.

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

This information is not applicable. This is a laser surgical instrument, not an AI diagnostic device. No MRMC study was conducted.

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

This information is not applicable. This is a physical laser device, not a standalone algorithm.

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

This information is not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior clearances and clinical use. No new ground truth data of this type was generated for this submission.

8. The sample size for the training set

This information is not applicable. This is a medical device clearance based on substantial equivalence, not an AI model requiring a training set.

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

This information is not applicable. As above, there was no training set for an AI model.

Summary

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pg 1 of 4

1 2011

. !!!!!

510(k) Summary 5.

Submitter:	Fotona d.d.Stegne 71210 Ljubljana, SloveniaPhone: +386 15009100Fax: +386 5009 200
Contact Person:	Stojan Trošt, QA&RA ManagerPhone: + 386 1 5009 299E-mail: stojan.trost@fotona.si
Date:	May 5, 2010
Device Trade Name:	Fotona Dynamis Er:YAG/Nd:YAG Laser System Family
Common name:	Er:YAG/Nd:YAG Surgical Laser
Classification name:	GEX / Powered Laser Surgical Instrument;ORK / Laser Assisted Lipolysis

DEVICE DESCRIPTION

510(k) Submission: Fotona Dynamis Laser System Family -v13

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The Fotona Dynamis Laser System Family is designed to operate in five configurations (models):

XS Dynamis: Single Er:YAG laser system ।
XP Dynamis: Single Nd:YAG laser system ।
SP Dynamis: Combined Er: YAG/Nd: YAG laser system ।
XP Spectro: Single Nd:YAG laser system, with lower average output power of Nd:YAG laser and smaller housing
SP Spectro: Combined Er:YAG/Nd:YAG laser system, with lower average output power of -Nd:YAG laser and unchanged specifications of Er:YAG laser, and smaller housing.

INTENDED USE

The Fotona Dynamis Laser System Family, and its accessories, are intended for use in the following procedures:

Dynamis Er: YAG laser (2940 nm wavelength)

Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and skin resurfacing;
ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; l
Oral/Maxillofacial Indications: Oral and glossal lesions; l
Ophtalmology Indications: Soft tissue surrounding the eye; l
Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial । neoplasia), cysts, condiloma;
General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft l 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;
Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; ।

Dynamis Nd: YAG laser (1064 nm wavelength):

Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft । tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy;
Laser assisted lipolysis; ।
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin;
Treatment of wrinkles; -
Treatment of mild to moderate inflammatory acne vulgaris; -
Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins:
Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.

510(k) Submission: Fotona Dynamis Laser System Family -v13

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

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The Fotona Dynamis Laser system family has the same technological and design characteristics (design, chemical composition, energy source; wavelength, active medium, cooling system, power supply, beam delivery, controls, housing) as the previously cleared devices. The output characteristics are for the intended use the same as those of the predicate devices. All systems are based on VSP (Variable Square Pulse) power supply technology. 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 Fotona Dynamis Laser System family are identical to the predicate devices when used for similar clinical applications.

A comparison of the technical specifications for the intended use of the Dynamis system family with the previously cleared devices is provided in Table A (for the Nd: YAG wavelength) and Table B (for the Er:YAG wavelength) below.

	Fotona XP PlusNd:YAG Family ofLaser Systems(K050293)	Fotona XP Nd:YAGLaser System(K090126)	Fotona DynamisLaser SystemFamily
Wavelength	1064 nm	1064 nm	1064 nm
Laser media	Flashlamp pumpedsolid state rod	Flashlamp pumpedsolid state rod	Flashlamp pumpedsolid state rod
Aiming beam	650 nm	650 nm	650 nm
Output mode	Pulsed	Pulsed	Pulsed
Pulse energy	up to 120 J	up to 10 J	up to 50 J
Pulsewidth	1 – 200 ms	0.1-50 ms	0.1 - 50 msec
Repetition rate	up to 12 Hz	up to 64 Hz	up to 50 Hz
Power	up to 120 W	up to 30 W	up to 80 W
Beam delivery	Fiber	Fiber	Fiber
User interface	Push button control	Push button control	Push button control

Table A: Comparison table for Nd:YAG laser wavelength

Table B: Comparison table between the Fotona Dynamis and previosly cleared Fotona's and other devices for the Er:YAG laser wavelength

Er:YAG 2940 nm	Fotona Fidelis III (K093162)	Fotona Dualis SP (K021548)	Fotona Dynamis Family
Wavelength	2940 nm	2940 nm	2940 nm
Laser media	Flashlamp pumped solid state rod	Flashlamp pumped solid state rod	Flashlamp pumped solid state rod

510fk) Submission: Fotona Dynamis Laser System Family -v13

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K10(306 pg 4 of 4

Er:YAG 2940nm	Fotona Fidelis III(K093162)	Fotona Dualis SP(K021548)	Fotona Dynamis Family
Aiming beam	650 nm	650 nm	650 nm
Output mode	Pulsed	Pulsed	Pulsed
Pulse energy	25 - 1500 mJ	40 - 1000 mJ	30 - 1500 mJ
Pulsewidth	50 – 1000 μs	75 - 950 μs	100 – 1500 μs
Repetition rate	up to 50 Hz	up to 30 Hz	up to 50 Hz
Power	up to 20 W	up to 15 W	up to 20 W
Beam Delivery	Articulated arm	Articulated arm	Articulated arm
User interface	Touch screen and pushbutton control	Push button control	Push button control

STATEMENT OF SUBSTANTIAL EQUIVALENCE

The Fotona Dynamis Er:YAG/Nd:YAG Laser System Family is substantially equivalent to Fotona Dualis SP Nd:YAG/Er:YAG Laser System (K021548), Fotona Fidelis III Er:YAG/Nd: YAG Laser System (K093162), Fotona XP Nd:YAG Laser System (K090126) and Fotona XP Plus Nd:YAG Family of Laser Systems (K050293). The Fotona Dynamis Er: YAG/Nd:YAG Laser System Family is substantially equivalent in terms of indications for use and technology based on technical characteristics.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, represented by three curved lines that suggest the bird's wings and body. The eagle is a common symbol of the United States, and its presence in the logo signifies the department's role in serving the health and well-being of the nation.

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

Foona-d-d. % Mr. Stojan Trošt Quality Assurance and Regulatory Affairs Manager Stegne 7 1210 Ljubljana, Slovenia

JUL - 1 20H

Re: K101306

Trade/Device Name: Fotona Dynamis Er:YAG/Nd:YAG Laser System Family 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: GEX Dated: June 24, 2011 Received: June 28, 2011

Dear Mr. Trošt:

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.

{5}------------------------------------------------

Page 2 - Mr. Stojan Trošt

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1118001,'pplf.com the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/McdicalDevices/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 Small Manufacturers, International and Consumer Assistance at its toll/free no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.

Sincerely yours,
E.L. Keith

ar Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

K101306

g | of |

510(k) Number (if known):

Device Name: Fotona Dynamis Er: YAG/Nd: YAG Laser System Family

Indications For Use:

Dynamis Er: YAG laser (2940 nm wavelength)

Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin l tags, keratoses and skin resurfacing;
ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; ।
Oral/Maxillofacial Indications: Oral and glossal lesions; l
Ophtalmology Indications: Soft tissue surrounding the eye ; ।
Gynecology Indications: Herpes simplex, endometrial adhesion, CN (Cervical intraepithelial । neoplasia), cysts, condiloma;
General Surgery Indications: Surgical incision/excision 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, tissue ablation and vessel coagulation is necessary;
Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy; ।

Dynamis Nd:YAG laser (1064 nm wavelength):

Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy;
Laser assisted lipolysis; ।
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin:
Treatment of wrinkles; ー
Treatment of mild to moderate inflammatory acne vulgaris; ー
Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins:
Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.

Prescription Use: X

AND/OR

Over-The-Counter Use:

(21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Division of Surgical, Orthopedic,

510(k) Numbe

510(k) Submission: Fotona Dynamis Laser System Famild Restorative Devices

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.