(417 days)
Not Found
No
The summary describes a laser system with different wavelengths and configurations for various surgical and dermatological procedures. There is no mention of AI or ML in the intended use, device description, or any other section. The technology described is based on laser physics and pulse control (VSP Technology), not data-driven algorithms.
Yes
The device is described with indications for use in treating various medical conditions and performing surgical procedures, which aligns with the definition of a therapeutic device.
No
The device description and intended use indicate that the Fotona Dynamis Laser System Family is used for surgical procedures, tissue modification (e.g., resurfacing, ablation, coagulation), and treatment of various conditions (e.g., hair removal, wrinkle treatment), not for diagnosing medical conditions.
No
The device description clearly outlines a physical laser system with hardware components (laser unit, console, articulated arm, hand pieces, optical fiber delivery system, footswitch). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical and dermatological procedures performed directly on the patient's body. This includes cutting, excising, vaporizing, coagulating, and treating various tissues and conditions.
- Device Description: The device is a laser system that delivers energy to the patient's tissues. It uses articulated arms or fiber optic delivery systems to direct the laser beam.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The Fotona Dynamis Laser System Family is a therapeutic medical device used for various surgical and non-surgical treatments on the patient.
N/A
Intended Use / Indications for 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;
- 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ORK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Epidermal, ENT lesions, Oral and glossal lesions, Soft tissue surrounding the eye, Cervical, Genital, Internal organs, Skin, Muscle, Cartilage, Meniscus, Mucous membrane, Lymph vessels and nodes, Organs and glands, Hair, Pigmented and vascular lesions, Varicose veins.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K021548, K093162, K090126, K050293
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
pg 1 of 4
- 1 2011
. !!!!!
510(k) Summary 5.
| Submitter: | Fotona d.d.
Stegne 7
1210 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.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
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.
510(k) Submission: Fotona Dynamis Laser System Family -v13
1
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 Plus
Nd:YAG Family of
Laser Systems
(K050293) | Fotona XP Nd:YAG
Laser System
(K090126) | Fotona Dynamis
Laser System
Family |
|-----------------|------------------------------------------------------------------|-----------------------------------------------|------------------------------------------|
| Wavelength | 1064 nm | 1064 nm | 1064 nm |
| Laser media | Flashlamp pumped
solid state rod | Flashlamp pumped
solid state rod | Flashlamp pumped
solid 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
3
K10(306 pg 4 of 4
| Er:YAG 2940
nm | 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 push
button 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.
4
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
6
4. Indications for Use Statement
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