(114 days)
Not Found
No
The description focuses on laser technology and its physical properties, with no mention of AI, ML, or image processing for analysis or decision-making.
Yes.
The device is intended for various medical treatments, including the removal of tattoos, treatment of skin lesions, hair removal, and skin resurfacing, all of which are therapeutic indications.
No
This device is a therapeutic laser system used for various treatments such as tattoo removal, hair removal, skin resurfacing, and treatment of vascular and pigmented lesions. It does not perform any diagnostic functions.
No
The device description clearly details hardware components such as a laser cavity, crystals, flashlamps, articulated arm, and handpieces, indicating it is a physical laser system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The StarWalker Laser System Family is a laser system used for various dermatological and cosmetic procedures, including tattoo removal, hair removal, treatment of pigmented and vascular lesions, and skin resurfacing. It operates by directing laser energy onto the skin.
- Lack of Biological Sample Analysis: The device description and intended use clearly indicate that the system works directly on the patient's body and does not involve the analysis of biological samples.
Therefore, the StarWalker Laser System Family falls under the category of therapeutic or surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The StarWalker Laser System Family is indicated for:
Specific Indications:
1064 nm wavelength in Q-switched mode:
- Removal of dark (black, blue, brown) tattoo ink l
- 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 —
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 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 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
- Sky blue (light) tattoo ink removal
- -Green tattoo tattoo ink removal
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)
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Fotona StarWalker Laser System Family 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:YAG 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. Both lasers are used in non-contact mode. The user activates laser emission by means of a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
No clinical testing was needed.
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 18, 2017
Fotona d.o.o. Stojan Trost QA&RA Manager Stegne 7 Ljubljana, 1000 Si
Re: K171227
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: August 16, 2017 Received: July 20, 2017
Dear Stojan Trost:
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 Actinclude 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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" (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 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.
Sincerelv.
Jennifer R. Stevenson -S3
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
4 Indications for Use Statement
510(k) Number (if known): K171227
Device Name: StarWalker Laser System Family
Indications For Use:
The StarWalker Laser System Family is indicated for:
Specific Indications:
1064 nm wavelength in Q-switched mode:
- Removal of dark (black, blue, brown) tattoo ink l
- 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 —
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 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 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
3
- 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
- Sky blue (light) tattoo ink removal
- -Green tattoo tattoo ink removal
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)
| Prescription Use: | X |
|---|---|
| (21 CFR 801 Subpart D) C) | |
| AND/OR | |
| Over-The-Counter Use: | |
| (21 CFR 807 Subpart |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
5 510(k) Summary
5.1 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: | Stojan Trošt, QA&RA Manager | |
| Phone: + 386 1 5009 299 | ||
| E-mail: stojan.trost@fotona.com | ||
| Date: | August 17, 2017 |
5.2 DEVICE INFORMATION
| Device Trade Name: | StarWalker Laser System 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 |
5.3 PREDICATE DEVICES
- . Fotona QX ND:YAG/KTP Laser System Family (K083889)
- Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) •
- . Fotona Dynamis Pro Family (K143723)
5
5.4 DEVICE DESCRIPTION
The Fotona StarWalker Laser System Family 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:YAG 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. Both lasers are used in non-contact mode. The user activates laser emission by means of a footswitch.
5.5 INTENDED USE
The Fotona StarWalker Laser System Family, and its accessories, are intended 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
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 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 ー
- Green tattoo tattoo ink removal -
- Treatment of benign pigmented lesions including, but not limited to: ー
- cafe-au-lait birthmarks —
- solar lentigines ।
6
- senile lentigines —
- senile lentigines
- Becker's nevi -
- freckles
- common nevi ー
- 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 —
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)
5.6 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The Fotona StarWalker 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 variable pulse duration 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 StarWalker 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 StarWalker Laser System Family with the previously cleared devices is provided in Table A and Table B.
| Nd:YAG laser
wavelength | Fotona QX Nd:YAG/KTP
LaserSystem Family
(K083889) | Fotona Dynamis Pro
Family (K143723) | Fotona StarWalker Laser
System Family (this
submission) |
|-----------------------------------|----------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------|
| 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 | 635 nm | 650 nm | 635 nm |
| Output mode | Pulsed | Pulsed | Pulsed |
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) | Fotona Dynamis Pro
Family (K143723) | Fotona StarWalker Laser
System Family (this
submission) |
|----------------------------|---------------------------------------------------------|----------------------------------------|---------------------------------------------------------------|
| Pulse energy | up to 1.6 J (Q-switched)
up to 5 J (long pulsed) | Up to 50 J (long pulsed) | up to 1.6 J (Q-switched)
up to 15 J (long pulsed) |
| Pulsewidth | 5 - 20 ns (Q-switched)
0.25 ms (long pulsed) | 0.1 - 50 ms (long pulsed) | 5 - 20 ns (Q-switched)
0.6 - 50 ms (long pulsed) |
| Repetition rate | up to 10 Hz | Up to 100 Hz | up to 15 Hz |
| Beam delivery | Articulated arm | Fiber | Articulated arm |
| User interface | Push button control | Touch screen | Touch screen |
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 QX Nd:YAG/KTP
Laser System Family
(K083889) | Fotona Dualis KTP (532
nm) Laser System
(K011939) | Fotona StarWalker Laser
System Family |
|-----------------|----------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------|
| Wavelength | 532 nm | 532 nm | 532 nm |
| Laser media | Flashlamp pumped solid
state rod | Flashlamp pumped solid
state rod | Flashlamp pumped solid
state rod |
| Aiming beam | 635 nm | 650 nm | 635 nm |
| Output mode | Pulsed | Pulsed | Pulsed |
| Pulse energy | up to 0.6 J (Q-switched) | Up to 3.7 J (long pulsed) | Up to 0.6 J (Q-switched)
Up to 2 J (long pulsed) |
| Pulsewidth | 5-20 ns (Q-switched) | 1 - 150 ms (long pulsed) | 5-20 ns (Q switched)
15 - 50 ms (long pulsed) |
| Repetition rate | up to 10 Hz | up to 10 Hz | up to 10 Hz |
| Beam delivery | Articulated arm | Fibre - optic | Articulated arm |
| User interface | Push button control | Push button control | Touch screen |
5.7 STATEMENT OF SUBSTANTIAL EQUIVALENCE
The Fotona StarWalker Laser System Family is substantially equivalent to Fotona QX Nd:YAG/KTP Laser System Family (K083889), Fotona Dualis KTP (532 nm) Laser System and Accessories (K011939) and Fotona Dynamis Pro Family (K143723). The Fotona StarWalker Laser System Family is substantially equivalent in terms of indications for use and technology based on technical characteristics.
5.8 TESTING
Clinical testing:
No clinical testing was needed.
Fotona StarWalker laser system family is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards
8
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 compatibility - 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 17664:2004
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
EN ISO 10993-1:2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- For international compliance see CB Scheme standards
- The standard EN 60601-2-22:2013 and EN 60601-1-2:2015 have been published but not harmonized yet. It is however our decision to follow the current state of the art assuming the newer standards assure a higher level of safety.
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 compatibility - 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 62304:2006 + A1:2015
Medical device software - Software life-cycle processes.
Laboratory testing has been conducted to validate and verify that the proposed Fotona StarWalker laser system family meets all design specifications and is substantially equivalent to the predicate devices.