(90 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.
Yes
The device is clearly indicated for various medical treatments and procedures, including surgical incisions, tissue ablation, coagulation, and treatment of numerous medical conditions.
No
Explanation: The device is a laser system intended for surgical procedures such as incision, cutting, ablation, vaporization, and coagulation of various soft and hard tissues, as well as hair removal and treatment of certain skin conditions. Its stated uses are therapeutic and surgical, not diagnostic.
No
The device description clearly outlines a physical laser unit with optical components, handpieces, and a power source, indicating it is a hardware device, not software-only.
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 taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that the Dynamis Er: YAG and Nd:YAG lasers are intended for surgical procedures involving the direct interaction with and modification of soft and hard tissue within the body. This includes incision, cutting, ablation, vaporization, coagulation, and hemostasis.
- Intended Use/Indications: All the listed indications involve treating conditions or performing procedures directly on the patient's body, not analyzing samples taken from the body.
- Device Description: The description details a laser system with handpieces and delivery systems designed for direct application to tissue. There is no mention of components for handling or analyzing biological specimens.
The device is a therapeutic laser system used for surgical and dermatological procedures, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Er: Y AG laser (2940 nm wavelength):
The Dynamis Er: Y AG laser is intended for surgical incision, 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;
- Soft tissue resurfacing with S22 and S22-T scanner;
- 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, 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 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;
Nd:YAG laser (1064 nm wavelength):
The Dynamis Nd:YAG laser is intended for incision, ablation, vaporization and hemostasis of vascular lesions and soft tissue in various dermatological 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, strated 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 thair 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 wrinkles with S11 scanner;
-
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
- Radical nail excision
- Periungual and subungual warts
- Plantar warts
- Neuromas
-
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 varicosities.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Dynamis Pro 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: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.
The Dynamis Pro Family is designed to operate in single wavelength (Nd:YAG or Er:YAG) configurations (models) and dual wavelength (Nd:YAG and Er:YAG) configurations (models).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft and hard tissue, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, glands, ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia, Oral and glossal lesions, Soft tissue surrounding the eye, Internal organs, Cervical, external genitalia, urethra, anus, penis, scrotum, vulvar, colon, warts, plantar verrucae, nails, Aphthous Ulcers, Herpex Simplex I and II, vascular lesions, pigmented lesions, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins, spider veins, incompetent tributary veins associated with varicosities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Laboratory testing has been conducted to validate and verify that the Dynamis Pro Family meets all design specifications and is substantially equivalent to the predicate device.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Fotona d.o.o. Marko Berdajs Quality Assurance and Regulatory Affairs Stegne 7 1000 Ljubljana. SI
October 31, 2018
Re: K182088
Trade/Device Name: 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 Dated: July 27, 2018 Received: August 2, 2018
Dear Marko Berdajs:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| 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 |
Neil R.P. Ogden
Digitally signed by Neil R.P. Ogden
Date: 2018.10.31 14:40:56 -04'00'Enclosure
2
Indications for Use
510(k) Number (if known) K182088
Device Name Dynamis Pro Family
Indications for Use (Describe) Er: Y AG laser (2940 nm wavelength):
The Dynamis Er: Y AG laser is intended for surgical incision, 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;
- Soft tissue resurfacing with S22 and S22-T scanner;
- 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, 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 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;
Nd:YAG laser (1064 nm wavelength):
The Dynamis Nd:YAG laser is intended for incision, ablation, vaporization and hemostasis of vascular lesions and soft tissue in various dermatological areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.
- Surgical incison, excision, vaporization, ablation of soft tissue. All soft tissue is included, strated 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;
3
-
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 thair 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 wrinkles with S11 scanner;
-
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
- Radical nail excision
- Periungual and subungual warts
- Plantar warts
- Neuromas
-
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 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
SUBMITTER'S INFORMATION
| Submitter: | Fotona d.o.o.
Stegne 7
1000 Ljubljana, Slovenia
Phone: +386 1 5009 100
Fax: +386 1 5009 200 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Marko Berdajs, Quality Assurance and Regulatory Affairs
Phone: +386 1 5009 119
E-mail: marko.berdajs@fotona.com |
| Date: | October 30, 2018 |
DEVICE INFORMATION
| Device Trade Name: | Dynamis Pro Family |
|---|---|
| Common name: | Medical Laser System |
| Classification name: | GEX-Powered Laser Surgical Instrument, General and Plastic |
| Surgery | |
| 21 CFR 878.4810, Class II | |
| Product Code: | GEX |
PREDICATE DEVICE
- . Fotona Dynamis Pro Family (K143723)
DEVICE DESCRIPTION
The Dynamis Pro 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:YAG laser). Optionally, the Nd:YAG therapeutic and
5
aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end.
The Dynamis Pro Family is designed to operate in single wavelength (Nd:YAG or Er:YAG) configurations (models) and dual wavelength (Nd:YAG and Er:YAG) configurations (models).
INTENDED USE
The Dynamis Pro Family and its accessories, will have the same intended use as predicate device and will be marketed for the following indications for use:
Er:YAG laser (2940 nm wavelength)
The 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;
-
Soft tissue resurfacing with S22 and S22-T scanner;
-
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;
Nd:YAG laser (1064 nm wavelength):
6
The 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 wrinkles with S11 scanner;
-
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
-
Radical nail excision
-
Periungual and subungual warts
-
Plantar warts
-
Neuromas
-
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.
SUBSTANTIAL EQUIVALENCE DISCUSSION
The 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 device Fotona Dynamis Pro Family (K143723).
The output characteristics for the intended use are the same as those of the predicate device. Both lasers utilize class I aiming beam which pose no hazard to the user. Both systems are microprocessor controlled devices. The microprocessor control regulates normal operation, permits parameter selection and avoids hazard incidence. Both 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 Dynamis Pro Family are identical to the predicate device.
7
The difference between the subject device and previously cleared device under K143723 is as follows. Additional optical manual and scanner Nd:YAG and Er:YAG hand pieces are added to the list of acessories for the Dynamis Pro Family. Further, the Dynamis Pro Family and its accessories will be marketed for the following additional indications:
Er: YAG laser (2940 nm wavelength):
·Soft tissue resurfacing with S22 and S22-T scanner
Nd:YAG laser (1064 nm wavelength):
·Treatment of wrinkles with S11 scanner
5.1 TESTING
The Dynamis Pro Family has been evaluated via verification and validation tests and inspections for conformance to applicable regulations and safety standards. Dynamis Pro Family is designed, tested and will be manufactured in accordance with both, mandatory and voluntary standards.
EN 60601-1:2006; EN 60601-1:2006/A1:2013
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1-2:2007
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility - Requirements and tests.
EN 60601-1-6:2010 + A1:2015
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
EN 60601-2-22:2013 ↓
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
EN 60825-1:2014
Safety of laser products. Part 1: Equipment classification and requirements.
EN ISO 10993-1:2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
EN ISO 14971:2012
Medical devices - application of risk management to medical devices
EN 62304:2006
Medical device Software - software life-cycle process
EN ISO 17664:2004
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
EN 62366:2008; EN 62366:2008/A1:2015
Medical devices - Application of usability engineering to medical devices
· The particular standard EN 60601-2-22:2013 has been published but not harmonized yet, therefore EN 60601-2-22:1996 together with the basic standard EN 60601-1:1990 and its amendments are still effective. It is however our decision to follow the current state of the art assuming the newer standards assure a higher level of safety.
IEC 60601-1:2005 + A1:2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2007
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-6:2010 + A1:2013
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability
IEC 60601-2-22:2007 + A1:2012
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential
8
performance of surgical, cosmetic, therapeutic and diagnostic laser equipment IEC 60825-1:2014 Safety of laser products. Part 1: Equipment classification and requirements. IEC 62304:2006 Medical device Software - software life-cycle process IEC 62366:2007 + A1:2014 Medical devices - Application of usability engineering to medical devices
Laboratory testing has been conducted to validate and verify that the Dynamis Pro Family meets all design specifications and is substantially equivalent to the predicate device.
STATEMENT OF SUBSTANTIAL EQUIVALENCE
The Dynamis Pro Family shares similar indications for use, same design and functional features with predicate device, and therefore Fotona believes that its newly submitted Dynamis Pro Family is substantially equivalent to the Fotona Dynamis Pro Family (K143723).