The Fotona Dynamis Er: YAG laser is intended for surgical incision/excision, cutting ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.

· Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue 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 ;

· Intra-oral soft tissue incision, excision, ablation, coagulation;

· 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;

· Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;

· Genitourinary Indications:lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon;

· Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;

· 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/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;

· The Fotona FS-01 Handpiece is intended for:

Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;

Dynamis Nd:YAG laser (1064 nm wavelength):

The Fotona Dynamis Nd: YAG laser is intended for incision, ablation, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.

· 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;

· Treatment of Aphthous Ulcers; · Excision and Vaporization of Herpex Simplex I and II; · Laser assisted uvulopaletoplasty (LAUP); · 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. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regime: · 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; · Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: o Matrixectomy o Radical nail excision o Periungual and subungual warts o Plantar warts o Neuromas o Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) · Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.

Device Description

The Fotona Dynamis Pro 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 beams 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 handpiece (in the case of the Nd: Y AG 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 Pro Family is designed to operate in single wavelength (Nd:Y AG or Er: Y AG) configurations (models) and dual wavelength (Nd: Y AG and Er: Y AG) configurations (models).

AI/ML Overview

The provided document describes the Fotona Dynamis Pro Family laser system, a medical device for surgical procedures. It seeks to establish substantial equivalence to previously cleared predicate devices rather than present a study with specific acceptance criteria and performance data for a new, AI-driven diagnostic or prognostic device.

Therefore, the requested information for acceptance criteria and a study proving device performance (including sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not directly available in this document. This document is a 510(k) premarket notification for a laser surgical instrument, which typically relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, rather than requiring extensive clinical performance studies with acceptance criteria in the way an AI diagnostic tool would.

Here's a breakdown of what can be extracted or inferred based on the document's nature:

1. A table of acceptance criteria and the reported device performance:

This document does not present specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) or a detailed clinical study comparing the device to a gold standard with predefined thresholds. Instead, the "acceptance criteria" are implied by substantial equivalence to predicate devices. The "reported device performance" is largely framed by its technical specifications matching or being similar to those of its predicates for similar intended uses.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Fotona Dynamis Pro Family)
Er:YAG (2940 nm) Wavelength:
- Wavelength: 2940 nm	2940 nm
- Laser Media: Flashlamp pumped solid state Er:YAG rod	Flashlamp pumped solid state Er:YAG rod
- Aiming Beam: 650 nm	650 nm
- Output Mode: Pulsed	Pulsed
- Pulse Energy: 30 - 3000 mJ	30 - 3000 mJ
- Pulsewidth: 100 - 1500 µs	100 - 1500 µs
- Repetition Rate: up to 50 Hz	up to 50 Hz
- Power: up to 20 W	up to 20 W
- Beam Delivery: Articulated arm	Articulated arm
- User Interface: LCD Touchscreen	LCD Touchscreen
Nd:YAG (1064 nm) Wavelength:
- Wavelength: 1064 nm	1064 nm
- Laser Media: Flashlamp pumped solid state Nd:YAG rod	Flashlamp pumped solid state Nd:YAG rod
- Aiming Beam: 650 nm	650 nm
- Output Mode: Pulsed	Pulsed
- Pulse Energy: up to 50 J	up to 50 J
- Pulse Duration: 0.1 - 50 ms	0.1 - 50 ms
- Repetition Rate: up to 100 Hz	up to 100 Hz
- Power: up to 80 W	up to 80 W
- Beam Delivery: Fiber	Fiber
- User Interface: LCD Touchscreen	LCD Touchscreen
Safety and Performance Standards Compliance:	The device is designed, tested, and will be manufactured in accordance with listed mandatory and voluntary standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, EN ISO 14971, IEC 62304, ISO 17664, IEC 62366, IEC 60601-1-6).
Functional Equivalence:	The device is stated to be "substantially equivalent in terms of indications for use and technology based on technical characteristics" to the listed predicate devices. The risk and benefits are also stated to be "identical to the predicate devices when used for similar clinical applications."

No specific study with acceptance criteria for diagnostic/AI performance is described. The "study" mentioned is laboratory testing to validate and verify that the proposed device meets design specifications and is substantially equivalent to predicate devices. This type of testing focuses on engineering performance and safety, not clinical efficacy in a comparative AI context.

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

Not applicable. This isn't a diagnostic device using a test set of patient data. The "testing" involved laboratory verification and validation against design specifications and relevant standards.

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. No ground truth for a test set of patient data was established or used as this is a surgical laser device not an AI diagnostic tool.

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

Not applicable. No test set requiring expert adjudication was used.

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. This device is a laser surgical instrument, not an AI-assisted diagnostic tool. No human reader performance, with or without AI, is relevant to its substantial equivalence determination.

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

Not applicable. This device is hardware (a laser system), not an algorithm.

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

Not applicable. For this type of device, the "ground truth" relates to its adherence to technical specifications, safety standards, and functional equivalence to its predicate devices, rather than a clinical ground truth like pathology or outcomes data in the context of an AI diagnostic study.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines representing hair or ribbons.

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

April 9, 2015

Fotona D. D. Mr. Stojan Trošt Quality Assurance & Regulatory Affairs Manager Stegne 7 1000 Ljubljana Slovenia

Re: K143723 Trade/Device Name: Fotona Dynamis Pro 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, ONG Dated: January 7, 2015 Received: January 9, 2015

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.

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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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/ResourcesforYou/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,

Jennifer R. Stevenson -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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Indications for Use

510(k) Number (if known) K143723

Device Name Fotona Dynamis Pro Family

Indications for Use (Describe)

** Dynamis Er: Y AG laser (2940 nm wavelength)

· Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue 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 ;

· Intra-oral soft tissue incision, excision, ablation, coagulation;

· Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;

· Genitourinary Indications:lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon;

· Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;

· 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:

· The Fotona FS-01 Handpiece is intended for:

Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;

**Dynamis Nd:YAG laser (1064 nm wavelength):

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5. 510(k) Summary

1. SUBMITTER'S INFORMATION

Name:	Fotona
Address:	Stegne 71000 Ljubljana, SloveniaPhone: +386 15009100+ 386 5009 200Fax:
Contact Person:	Stojan Trošt, QA&RA ManagerPhone: + 386 1 5009 299E-mail: stojan.trost@fotona.com

Date Prepared: Apr 9, 2015

2. DEVICE INFORMATION

Trade Name:	Fotona Dynamis Pro Family
Common Name:	Er:YAG/Nd:YAG Surgical Laser
Classification Name:	Powered laser surgical instrument with microbeam\fractional output

Product Code: ONG, GEX

3. PREDICATE DEVICES

Fotona Dynamis Laser System Family (K101306)
Fotona F-22 Laser Handpiece, Fotona FS-01 Laser Handpiece (K132806)
Fotona XP Nd: YAG Laser System Family (K113702)
Fotona Fidelis III Er: YAG/Nd: YAG Laser System Family (K093162)
Fotona XP Nd:YAG Laser System Family (K090126)
Fotona QX Nd: YAG/KTP Laser System Family (K083889)
Fotona XP Plus Nd:YAG Family of Laser Systems (K050293)
Fotona Fidelis Er: YAG Laser System & Accessories (K990243)

4. DEVICE DESCRIPTION

The Fotona Dynamis Pro 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

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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 beams 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 handpiece (in the case of the Nd: Y AG 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 Pro Family is designed to operate in single wavelength (Nd:Y AG or Er: Y AG) configurations (models) and dual wavelength (Nd: Y AG and Er: Y AG) configurations (models).

5. INTENDED USE

Dynamis Er:YAG laser (2940 nm wavelength)

The Fotona Dynamis Pro Er:YAG laser is intended for surgical incision/excision, cutting, ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.

Dermatology and Plastic Surgery Indications: Epidermal nevi. actinic cheilitis, . verrucae, skin tags, keratoses and soft tissue 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 ; .
Intra-oral soft tissue incision, excision, ablation, coagulation; .
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;
Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical ● intraepithelial neoplasia), cysts, condiloma;
Genitourinary Indications:lesions of the external genitalia, urethra and anus, . penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon;
Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, . matrixectomy;
The Fotona F-22 Handpiece is intended for: ●
In fractionated mode:

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Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;

In non-fractionated mode: -
- Surgical incision/excision, vaporization and General Surgery Indications: 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:

Dynamis Nd: YAG laser (1064 nm wavelength):

The Fotona Dynamis Pro Nd:YAG laser is intended for incision, ablation,vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skih types I - VI.

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;
Treatment of Aphthous Ulcers; ●
Excision and Vaporization of Herpex Simplex I and II; ●
Laser assisted uvulopaletoplasty (LAUP); ●
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. Permanent hair reduction is defined as the long-term. stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regime;
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;
. Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy o
- Radical nail excision o
- Periungual and subungual warts O
- Plantar warts o
- Neuromas o

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Temporary increase of clear nail in patients with onychomycosis (e.g., о dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.);
. Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The Fotona Dynamis Pro 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: Fotona Dynamis Er:YAG/Nd:YAG Laser System Family (K101306), Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (K132806), Fotona XP Nd:YAG Laser System Family (K113702), Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family (K093162), Fotona XP Nd:YAG Laser System Family (K090126), Fotona QX Nd:YAG/KTP Laser System Family (K083889), Fotona XP Plus Nd:YAG Family of Laser Systems (K050293), and Fotona Fidelis Er:YAG Laser System & Accessories (K990243).

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 Pro 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 Pro Family with the previously cleared devices is provided in Table 1 (for the Nd:YAG wavelength) and Table 2 (for the Er:YAG wavelength) below.

Er:YAG2940 nm	Fotona DynamisEr:YAG/Nd:YAGLaser SystemFamily(K101306)	Fotona FidelisEr:YAG LaserSystem &Accessories(K990243)	Fotona F-22 LaserHandpiece (F-Runner), FotonaFS-01 LaserHandpiece(K132806)	Fotona Fidelis IIIEr:YAG/Nd:YAGLaser SystemFamily(K093162)	Fotona DynamisPro Family(newsubmission)
Wavelength	2940 nm	2940 nm	2940 nm	2940 nm	2940 nm
Laser media	Flashlamp pumpedsolid stateEr:YAG rod	Flashlamp pumpedsolid stateEr:YAG rod	Flashlamp pumpedsolid stateEr:YAG rod	Flashlamp pumpedsolid stateEr:YAG rod	Flashlamp pumpedsolid stateEr:YAG rod
Aiming beam	650 nm	650 nm	650 nm	650 nm	650 nm
Output mode	Pulsed	Pulsed	Pulsed	Pulsed	Pulsed
Pulse energy	30 - 3000 mJ	40 - 1000 mJ	30 - 3000 mJ	20 - 1500 mJ	30 - 3000 mJ
Pulsewidth	100 - 1500 µs	75 – 1000 µs	100 - 300 µs	50 – 1000 µs	100 - 1500 µs

Table 1: Comparison table of the technical output characteristics for the intended use between the Fotona Dynamis Family and previously cleared devices for the Er:Y AG laser wavelength

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Repetition rate	up to 50 Hz	up to 50 Hz	up to 50 Hz	up to 50 Hz	up to 50 Hz
Power	up to 20 W	up to 15 W	up to 20 W	up to 20 W	up to 20 W
Beam Delivery	Articulated arm	Articulated arm	Articulated arm	Articulated arm	Articulated arm
User interface	Push button control	Push button control	Push button control	LCD Touchscreen	LCD Touchscreen

Table 2: Comparison table of the technical output characteristics for the intended use between the Fotona Dynamis Family and previously cleared devices for the Nd: Y AG laser wavelength

Nd:YAG	Fotona DynamisLaser System Family(K101306)	Fotona XPNd:YAG LaserSystem Family(K113702,K090126)	Fotona XP PlusNd:YAG Family ofLaser Systems(K050293)	Fotona QXNd:YAG/KTPLaser SystemFamily(K083889)	Fotona Fidelis IIIEr:YAG/Nd:YAGLaser SystemFamily(K093162)	Fotona DynamisPro Family(new submission)
Wavelength	1064 nm	1064 nm	1064 nm	1064 nm	1064 nm	1064 nm
Laser media	Flashlamp pumpedsolid stateNd:YAG rod	Flashlamp pumpedsolid stateNd:YAG rod	Flashlamp pumpedsolid stateNd:YAG rod	Flashlamp pumpedsolid stateNd:YAG rod	Flashlamp pumpedsolid stateNd:YAG rod	Flashlamp pumpedsolid stateNd:YAG rod
Aiming beam	650 nm	650 nm	650 nm	650 nm	650 nm	650 nm
Output mode	Pulsed	Pulsed	Pulsed	Pulsed	Pulsed	Pulsed
Pulse energy	up to 50 J	up to 20 J	up to 120 J	5J	up to 10J	up to 50 J
Pulse duration	0.1 - 50 ms	0.1-50 ms	0.1-300 ms	0.25 ms	0.1-25 ms	0.1 - 50 ms
Repetition rate	up to 100 Hz	up to 100 Hz	up to 75 Hz	0.5 - 2.2 Hz	up to 100 Hz	up to 100 Hz
Power	up to 80 W	up to 30 W	up to 130 W	11W	up to 15 W	up to 80 W
Beam delivery	Fiber	Fiber	Fiber	Articulated arm	Fiber	Fiber
User interface	Push button control	Push button control	Push button control	Push button control	LCD Touchscreen	LCD Touchscreen

7. STATEMENT OF SUBSTANTIAL EQUIVALENCE

The Fotona Dynamis Pro Family is 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), Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (K132806), Fotona XP Nd:YAG Laser System Family (K113702), Fotona Fidelis III Er:YAG/Nd:YAG Laser System Family (K093162), Fotona XP Nd:YAG Laser System Family (K090126), Fotona QX Nd:YAG/KTP Laser System Family (K083889), Fotona XP Plus Nd: YAG Family of Laser Systems (K050293), and Fotona Fidelis Er: Y AG Laser System & Accessories (K990243).

8. TESTING

Clinical testing:

No clinical testing was needed.

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Fotona Dynamis Pro Family is 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: EN 60601-1: . 2006/AC:2010 Medical electrical equipment. Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2007, EN 60601-1-2: 2007; EN 60601-1-2:2007/AC:2010 . Medical electrical equipment. Part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility -Requirements and tests.
IEC 60601-2-22: 2007: EN 60601-2-22:2013 General requirements for basic . safety and essential performance. Part 2: Particular requirements for safety diagnostic and therapeutic laser equipment.
IEC 60825-1: 2007; EN 60825-1: 2007 Safety of laser products. Part 1: . Equipment classification and reuirements.
EN ISO 14971: 2012 Medical devices - application of risk management to medical devices
IEC 62304:2005; 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
IEC 62366: 2007/ A1:2014; EN 62366: 2008 Medical devices Application of ● usability engineering to medical devices
IEC 60601-1-6: 2010; EN 60601-1-6: 2010 Medical electrical equipment Part . 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Laboratory testing has been conducted to validate and verify that the proposed Fotona Dynamis Pro Family meets all design specifications and is substantially equivalent to the predicate 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.