(101 days)
Not Found
No
The document describes a laser system for surgical procedures and hair removal. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is based on Er:YAG and Nd:YAG lasers with a variable pulse technology.
Yes
The device is described with numerous indications for use that directly address various medical conditions, diseases, and aesthetic concerns, such as surgical incision/excision, treatment of lesions, reduction of unwanted hair, treatment of wrinkles and acne, and addressing vascular lesions, which are all therapeutic interventions.
No.
The device is a therapeutic laser system intended for surgical procedures, not for diagnosing conditions.
No
The device description clearly outlines a hardware-based laser system with physical components like laser sources, an articulated arm, handpieces, and a footswitch. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Fotona Dynamis Pro Laser System Family is a surgical laser system that directly interacts with and modifies human tissue through incision, excision, cutting, ablation, vaporization, coagulation, and hemostasis. It is used for therapeutic and surgical procedures, not for analyzing samples outside the body.
- Intended Use: The intended use clearly describes surgical and dermatological procedures performed directly on the patient's body.
- Device Description: The description details a laser system with handpieces and fiber delivery systems designed for direct application to tissue.
Therefore, the Fotona Dynamis Pro Laser System Family falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Dynamis Er: Y AG laser (2940 nm wavelength)
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.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D)
Product codes
GEX, ONG
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
All soft tissue, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia; Oral and glossal lesions; Soft tissue surrounding the eye; external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon; Foot (Warts, plantar verrucae, large mosaic verrucae, matrixectomy, Periungual and subungual warts, Plantar warts, Neuromas, nail); Endometrial adhesion, CIN (Cervical intraepithelial neoplasia).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing:
No clinical testing was needed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K101306, K132806, K113702, K093162, K090126, K083889, K050293, K990243
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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)
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;
3
· 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. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
5. 510(k) Summary
1. SUBMITTER'S INFORMATION
| Name: | Fotona |
|---|---|
| Address: | Stegne 7 |
| 1000 Ljubljana, Slovenia | |
| Phone: +386 15009100 |
- 386 5009 200
Fax: |
| Contact Person: | Stojan Trošt, QA&RA Manager
Phone: + 386 1 5009 299
E-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
5
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:
6
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
7
- 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:YAG
2940 nm | Fotona Dynamis
Er:YAG/Nd:YAG
Laser System
Family
(K101306) | Fotona Fidelis
Er:YAG Laser
System &
Accessories
(K990243) | Fotona F-22 Laser
Handpiece (F-
Runner), Fotona
FS-01 Laser
Handpiece
(K132806) | Fotona Fidelis III
Er:YAG/Nd:YAG
Laser System
Family
(K093162) | Fotona Dynamis
Pro Family
(new
submission) |
|-------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Wavelength | 2940 nm | 2940 nm | 2940 nm | 2940 nm | 2940 nm |
| Laser media | Flashlamp pumped
solid state
Er:YAG rod | Flashlamp pumped
solid state
Er:YAG rod | Flashlamp pumped
solid state
Er:YAG rod | Flashlamp pumped
solid state
Er:YAG rod | Flashlamp pumped
solid state
Er: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
8
| 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 Dynamis
Laser System Family
(K101306) | Fotona XP
Nd:YAG Laser
System Family
(K113702,
K090126) | Fotona XP Plus
Nd:YAG Family of
Laser Systems
(K050293) | Fotona QX
Nd:YAG/KTP
Laser System
Family
(K083889) | Fotona Fidelis III
Er:YAG/Nd:YAG
Laser System
Family
(K093162) | Fotona Dynamis
Pro Family
(new submission) |
|-----------------|----------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------|
| Wavelength | 1064 nm | 1064 nm | 1064 nm | 1064 nm | 1064 nm | 1064 nm |
| Laser media | Flashlamp pumped
solid state
Nd:YAG rod | Flashlamp pumped
solid state
Nd:YAG rod | Flashlamp pumped
solid state
Nd:YAG rod | Flashlamp pumped
solid state
Nd:YAG rod | Flashlamp pumped
solid state
Nd:YAG rod | Flashlamp pumped
solid state
Nd: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.
9
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.