(108 days)
Not Found
No
The document describes a laser system with various wavelengths and modes for different dermatological and surgical procedures. It details the physical components and operation of the laser but makes no mention of AI or ML technology for image processing, diagnosis, or treatment planning.
Yes
The device is indicated for various medical treatments, including skin resurfacing, treatment of acne scars and wrinkles, removal of tattoos, treatment of benign pigmented and vascular lesions, hair removal, and incision, excision, ablation, and vaporization of soft tissue, all of which are considered therapeutic.
No
The device is a laser system indicated for various therapeutic procedures, such as tattoo removal, skin resurfacing, treatment of vascular and pigmented lesions, and hair removal. It is used to treat existing conditions rather than to diagnose them.
No
The device description clearly details a hardware-based laser system with an optical cavity, crystals, flashlamps, articulated arm, and handpieces. While it likely includes software for control, it is fundamentally a hardware device.
Based on the provided information, the StarWalker Laser System Family is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- StarWalker's Intended Use: The StarWalker Laser System Family is indicated for various therapeutic and aesthetic procedures performed directly on the patient's body. These include tattoo removal, hair removal, skin resurfacing, treatment of lesions, and soft tissue procedures.
- Device Description: The device description details a laser system that delivers energy to the patient's tissue, not a system for analyzing biological specimens.
Therefore, the StarWalker Laser System Family falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The StarWalker Laser System Family is indicated for:
1064 nm wavelength in Q-switched mode:
-Removal of dark (black, blue, brown) tattoo ink
-Treatment of nevus of ota
-Treatment of common nevi
-Removal and lightening of unwanted hair
-Skin resurfacing procedures for the treatment of acne scars and wrinkles
-Treatment of melasma
-General dermatology indications: Incision, excision, ablation and vaporization of soft tissue
1064 nm wavelength in long pulse mode:
-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
-Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
-Coagulation and hemostasis of soft tissue
-Treatment of wrinkles
-Treatment of mild to moderate inflammatory acne vulgaris
532 nm wavelength in Q-switched mode (nominal delivered energy of 585 mm with the optional 585 nm and 650 nm dye converter handpieces):
-Red, tan, purple and orange tattoo ink removal
-Sky blue (light) tattoo ink removal
-Green tattoo tattoo ink removal
-Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
-Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
-Seborrheic Keratosis
-Treatment of post-inflammatory hyperpigmentation
-Skin resurfacing procedures for the treatment of acne scars and wrinkles
-Removal of epidermal pigmented lesions
532 nm wavelength in long pulse mode:
-Incision, ablation vaporization, coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
-The treatment (hemostasis, color lightening, blanching, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia)
1064 nm wavelength in PICO mode:
-Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple
-Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
-Treatment of acne scars in Fitzpatrick Skin Types II-V
-Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV
532 nm wavelength in PICO mode:
-Tattoo removal in Skin Types I - III
-Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Fotona StarWalker Laser System Family is based on the previously cleared Fotona StarWalker Laser System Family (K171227). The device is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd: Y AG laser is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing variable spot handpiece. Optionally, the KTP Nd:YAG beam can be guided to a 585nm dye converter handpiece, or to a 650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or a 650 nm wavelength, correspondingly. The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
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)
Non-Clinical Summary:
The Fotona StarWalker Laser System Family has been evaluated via verification and validation tests and inspections for conformance to the applicable regulations and safety standards. The Fotona StarWalker Laser System is designed, tested and will be manufactured in accordance with both, mandatory and voluntary standards.
Clinical Summary:
Not Applicable.
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.
K171227, K083889, K011939, K191685, K173199, K113588
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 19, 2020
Fotona d.o.o. Anja Pucer Quality Assurance and Regulatory Affairs Stegne 7 Ljubljana, 1000 Slovenia
Re: K202172
Trade/Device Name: StarWalker 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 31, 2020 Received: August 3, 2020
Dear Anja Pucer:
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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or post-marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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-
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 https://www.fda.gov/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.
542 of the Act); 21 CFR 1000-1050.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202172
Device Name StarWalker
Indications for Use (Describe) The StarWalker Laser System Family is indicated for:
1064 nm wavelength in Q-switched mode:
-Removal of dark (black, blue, brown) tattoo ink
-Treatment of nevus of ota
-Treatment of common nevi
-Removal and lightening of unwanted hair
-Skin resurfacing procedures for the treatment of acne scars and wrinkles
-Treatment of melasma
-General dermatology indications: Incision, excision, ablation and vaporization of soft tissue
1064 nm wavelength in long pulse mode:
-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
-Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to,
port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
-Coagulation and hemostasis of soft tissue
-Treatment of wrinkles
-Treatment of mild to moderate inflammatory acne vulgaris
532 nm wavelength in Q-switched mode (nominal delivered energy of 585 mm with the optional 585 nm and 650 nm dye converter handpieces):
-Red, tan, purple and orange tattoo ink removal
-Sky blue (light) tattoo ink removal
-Green tattoo tattoo ink removal
-Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
-Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
-Seborrheic Keratosis
-Treatment of post-inflammatory hyperpigmentation
-Skin resurfacing procedures for the treatment of acne scars and wrinkles
-Removal of epidermal pigmented lesions
532 nm wavelength in long pulse mode:
-Incision, ablation vaporization, coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
-The treatment (hemostasis, color lightening, blanching, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia)
1064 nm wavelength in PICO mode:
-Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and
3
purple
-Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
-Treatment of acne scars in Fitzpatrick Skin Types II-V
-Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV
532 nm wavelength in PICO mode:
-Tattoo removal in Skin Types I - III
-Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
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4
510k Summary
SUBMITTER'S INFORMATION
Submitter:
| Fotona d.o.o.
Stegne 7
1000 Ljubljana, Slovenia
| Phone: +386 1 5009 100 |
|---|
| Contact Person: |
| Anja Pucer, Quality Assurance and Regulatory Affairs |
| Phone: + 386 1 5009 100 |
| E-mail: anja.pucer@fotona.com |
| Date: |
Novemebr 18, 2020
DEVICE INFORMATION
| Device Trade Name: | StarWalker |
|---|---|
| Common name: | Laser Surgical Instrument For Use In General And Plastic Surgery |
| And In Dermatology | |
| Classification name: | GEX-Powered Laser Surgical Instrument |
| 21 CFR 878.4810, Class II | |
| Product Code: | GEX |
PREDICATE DEVICES
StarWalker (K171227) Fotona QX ND:YAG/KTP Laser System Family (K083889) Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) PicoWay Laser System (K191685) PicoSure Workstation (K173199) SPECTRA Laser System (K113588)
DEVICE DESCRIPTION SUMMARY
The Fotona StarWalker Laser System Family is based on the previously cleared Fotona StarWalker Laser System Family (K171227).The device is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is
5
K202172
achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd: Y AG laser is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing variable spot handpiece. Optionally, the KTP Nd:YAG beam can be guided to a 585nm dye converter handpiece, or to a 650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or a 650 nm wavelength, correspondingly. The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size.
INTENDED USE/INDICATIONS FOR USE
1064 nm wavelength in Q-switched mode:
-Removal of dark (black, blue, brown) tattoo ink
-Treatment of nevus of ota
-Treatment of common nevi
-Removal and lightening of unwanted hair
-Skin resurfacing procedures for the treatment of acne scars and wrinkles
-General dermatology indications: Incision, excision, ablation and vaporization of soft tissue
-Treatment of melasma
1064 nm wavelength in long pulse mode:
-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
-Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
-Coagulation and hemostasis of soft tissue
-Treatment of wrinkles
-Treatment of mild to moderate inflammatory acne vulgaris
1064 nm wavelength in PICO mode:
-Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple
-Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
-Treatment of acne scars in Fitzpatrick Skin Types II-V
-Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV
532 nm wavelength in O-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):
-Red, tan, purple and orange tattoo ink removal
-Sky blue (light) tattoo ink removal
-Green tattoo ink removal
- Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
-Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
-Seborrheic Keratosis
-Treatment of post-inflammatory hyperpigmentation
-Skin resurfacing procedures for the treatment of acne scars and wrinkles
6
-Removal of epidermal pigmented lesions
532 nm wavelength in long pulse mode:
-The treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia)
-Incision, ablation vaporization, coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, subcutaneoous tissue, striated and smooth tissue, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
532 nm wavelength in PICO mode:
-Tattoo removal in Skin Types I - III
- -Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV
INDICATIONS FOR USE COMPARISON
The indications for use from the predicate laser devices that are now included in the Fotona StarWalker Laser System Family do not raise new types of questions regarding safety and effectiveness.
TECHNOLOGICAL COMPARISON
The Fotona StarWalker Laser System Family has either identical or similar applicable technological and design characteristics (design, chemical composition, energy source; wavelength, active medium, cooling system, power supply, beam delivery, controls, housing) as the predicate devices. The output characteristics (pulse width, pulse energy) are the same or similar as those of the predicate devices; the output parameters (fluence, pulsewidth) are the same for the particular intended use as those of the predicate devices.
| Nd:YAG laser
wavelength | Fotona QX
Nd:YAG/KTP
LaserSystem Family
(K083889) | PicoWay Laser
System
(K191685) | SPECTRA Q-
Switched
Nd:YAG Laser
System with Dye
Handpieces
(K113588) | Fotona StarWalker Laser
System Family (this submission) |
|-----------------------------------|------------------------------------------------------------|--------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Wavelength | 1064 nm | 1064 nm | 1064 nm | 1064 nm |
| Laser source | Nd:YAG laser | Nd:YAG laser | Nd:YAG laser | Nd:YAG laser |
| Output mode | Pulsed | Pulsed | Pulsed | Pulsed |
| Pulse energy | Up to 1.6 J (Q-switched)
Up to 5 J (long pulsed) | Up to 0.4 J | Up to 1.2 J (Q-
switched) | Up to 1.6 J (Q-switched)
Up to 15 J (long pulsed)
Up to 0.8 J (PICO Nd:YAG) |
| Pulsewidth | 5 - 20 ns (Q-switched)
0.25 ms (long pulsed) | 450 ps | 5 - 10 ns | 5 -20 ns (Q-switched)
0.6 - 50 ms (long pulsed)
300 - 400 ps (PICO Nd:YAG) |
| Repetition rate | Up to 10 Hz | 1 - 10 Hz | Up to 10 Hz | 0.5 - 15 Hz (Q-switched)
0.5 - 10 Hz (PICO Nd:YAG) |
Table A: Comparison table of the technical specifications for Nd:YAG laser of Fotona StarWalker Laser System Family, compared to previously cleared devices
7
| Nd:YAG laser
wavelength | Fotona QX
Nd:YAG/KTP
LaserSystem Family
(K083889) | PicoWay Laser
System
(K191685) | SPECTRA Q-
Switched
Nd:YAG Laser
System with Dye
Handpieces
(K113588) | Fotona StarWalker Laser
System Family (this submission) |
|-----------------------------------|------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------------------------|
| Beam delivery | Articulated arm with
handpieces | Articulated arm
with
handpieces | Articulated arm
with
handpieces | Articulated arm with
handpieces |
| User interface | Push button control | Touchscreen
with GUI | Touchscreen with
GUI | Touchscreen with GUI |
Table B: Comparison table of the technical specifications for Nd:YAG KTP laser of Fotona StarWalker Laser System Family, compared to previously cleared devices
| Nd:YAG KTP | Fotona Dualis
KTP (532 nm)
Laser System
(K011939) | SPECTRA Q-
Switched
Nd:YAG Laser
System with Dye
Handpieces
(K113588) | PicoWay
Laser System
(K191685) | PicoSure
Workstation
(K173199) | Fotona StarWalker Laser
System Family (this
submission) |
|-------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------------------------|-------------------------------------------------------------------------------|
| Wavelength | 532 nm | 532 nm | 532 nm | 532 nm | 532 nm |
| Laser source | Frequency-
doubled
Nd:YAG laser
(KTP) | Frequency-doubled
Nd:YAG laser
(KTP) | Frequency-
doubled
Nd:YAG laser
(KTP) | Frequency
doubled
Nd:YVO 4 | Frequency-doubled
Nd:YAG laser (KTP) |
| Output mode | Pulsed | Pulsed | Pulsed | Pulsed | Pulsed |
| Pulse energy | Up to 3.7 J (long
pulsed) | Up to 0.4 J | Up to 0.2 J | Up to 0.2 J | Up to 2 J (long pulsed)
Up to 0.6 J (Q-switched)
Up to 0.3 J (PICO KTP) |
| Pulsewidth | 1 – 150 ms
(long pulsed) | 5 - 10 ns | 375 ps | 450 - 900 ps | 15 - 50 ms (long pulsed)
5 - 20 ns (Q-switched)
300 - 400 ps (PICO KTP) |
| Repetition rate | Up to 10 Hz | Up to 10 Hz | 1 - 10 Hz | 1, 2.5, 5, 10 Hz | 0.5 - 1 Hz (long pulsed)
0.5 - 10 Hz (Q-switched)
0.5 - 8 Hz (PICO KTP) |
| Beam delivery | Fibre - optic | Articulated arm
with
handpieces | Articulated arm
with
handpieces | Articulated arm
with
handpieces | Articulated arm with
handpieces |
| User interface | Push button
control | Touchscreen with
GUI | Touchscreen
with GUI | Touchscreen | Touchscreen with GUI |
NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY AND CONCLUSIONS
Non-Clinical Summary:
The Fotona StarWalker Laser System Family has been evaluated via verification and validation tests and inspections for conformance to the applicable regulations and safety
8
K202172
standards. The Fotona StarWalker Laser System is designed, tested and will be manufactured in accordance with both, mandatory and voluntary standards.
EN-standards:
EN 60601-1:2006 + A1:2013 , Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance.
EN 60601-1-2:2015, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests.
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 60601-1-6:2010 + A1:2015. Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
EN 62366:2008 + A1:2015, Medical devices - Application of usability engineering to medical devices.
EN 60825-1:2014, Safety of laser products -- Part 1: Equipment classification and requirements.
EN ISO 14971:2012, Medical devices - Application of risk management to medical devices. EN 62304:2006 + A1:2015, Medical device software - Software life-cycle processes.
EN ISO 17664:2017, Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
CB Scheme standards:
IEC 60601-1:2005 + A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests.
IEC 60601-2-22:2007 + A1:2012, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
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 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 62366:2007 + A1:2014, Medical devices - Application of usability engineering to medical devices.
IEC 62366-1:2015 (state-ot-the-art edition), Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62304:2006 + A1:2015, Medical device software - Software life-cycle processes.
ISO standards:
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO 17664:2017, Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Clinical Summary:
9
Not Applicable.
Conclusions:
The Fotona StarWalker Laser System Family shares the applicable indications for use, similar technological characteristics, and similar design and functional features with the predicate devices. These do not raise new types of questions regarding safety and efficacy for the StarWalker Laser System Family when compared to the predicates. Based on its technical characteristics, design, functional features, performance test data, and its indications for use as listed above, the Fotona StarWalker Laser System Family is considered to be substantially equivalent to the predicate devices.