(92 days)
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No
The 510(k) summary describes a laser system for tattoo and lesion removal. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The description focuses on the laser's physical properties and operational parameters.
No.
The device is indicated for aesthetic applications such as tattoo removal, which falls under cosmetic procedures, not therapeutic ones.
No.
The device description indicates it is a laser used for tattoo and pigmented lesion removal, which is a treatment modality, not a diagnostic one.
No
The device description clearly outlines a hardware-based laser system with physical components like a Nd:YAG laser, KTP Optics, Pulse Slicing Module, articulated arm, and hand-pieces. While it mentions software verification and validation, this is in the context of controlling the hardware, not as a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "aesthetic applications for the following at the specified wavelength: Removal of tattoos". This is a therapeutic/aesthetic application performed directly on the patient's body.
- Device Description: The description details a laser system designed to deliver energy to the skin for tattoo removal. This is an external, non-diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. IVDs are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the NaturaLase PiQo4 is a medical device used for aesthetic treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
NaturaLase PiQo4 – The NaturaLase Nd: YAG 1064 Q-switched Laser with 532 KTP Optics and Pulse Slicing Module - is indicated for use in aesthetic applications at the specified wavelength:
532 mm - removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
1064 nm - Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat tattoo colors: black, brown, green, blue and purple
Product codes
GEX
Device Description
The NaturaLase PiQo4 laser is a Nd:YAG 1064 Q-Switched laser with 532 KTP Optics and Pulse Slicing Module. The 532 KTP Optics is available to convert the basic 1064 nm wavelength to 532 nm and the pulse slicing electro-optics allows diverting the leading and trailing portions of the laser pulse away from the delivery system for the purpose of shortening the pulse duration without reducing the peak power.
The NaturaLase PiO04 laser offers fast and efficient treatment of tattoos and benign pigmented lesions removal through a variety of spot sizes, fluences and repetition rates. The laser energy is delivered via an articulated arm with interchangeable hand-pieces. A liquid crystal display (LCD) provides visual feedback of control settings and operating parameters. The mechanism of action for tattoo or pigmented lesion removal lies in delivering laser energy at very high peak power.
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
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All performance testing demonstrated that the NaturaLase PiQo4 laser performs according to specifications and functions as intended.
Electrical safety and electromagnetic compatibility (EMC) testing for the NaturaLase PiQ04 laser system was conducted by an independent laboratory in accordance with IEC 60601-1, Medical electrical equipment, part 1: general requirements for basic safety and essential performance. The NaturaLase PiQo4 laser was determined to be in conformance with applicable IEC standards (IEC 62366, 60601-1, 60601-1-6, 60601-2-22, and IEC 60825-1). The biocompatibility of the NaruraLase PiQo4 laser is consistent with the ISO 10993. Software verification and validation testing results are acceptable for software release.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K142372 – PicoWay Laser System, Candela Corp.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The symbol is composed of three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2015
Focus Medical, LLC Michail M. Pankratov, MD, PhD MMP Medical Associates LLC 16 Appleton Street Waltham, Massachusetts 02453
Re: K151473
Trade/Device Name: NaturaLase PiQo4 - NaturaLase Nd: Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module 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 8, 2015 Received: July 10, 2015
Dear Dr. Pankratov:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151473
Device Name
NaturaLase PiQo4 - NaturaLase Nd: Y AG1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
Indications for Use (Describe)
NaturaLase PiQo4 - The NaturaLase Nd: Y AG 1064 O-switched Laser with 532 nm accessory and Pulse Slicing Module -is indicated for use in aesthetic applications for the following at the specified wavelength:
532 nm - Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
1064 nm - Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat tattoo colors: black, brown, green, blue and purple.
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中国际娱乐官网
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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510(K) SUMMARY
As required by section 21 CFR 807.92
I. General Information
| Applicant: | Focus Medical, LLC
2 Francis J Clarke Circle
Bethel, CT 06801
TEL: 203-730-8885
FAX: 203-730-8851 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michail M. Pankratov, MD, PhD
MMP Regulatory Consultants, LLC
16 Appleton Street
Waltham, MA 02453
TEL: 617-480-4543
clregconsult@aol.com |
| Preparation Date: | July 28, 2015 |
II. Device Information
| Trade Name: | NaturaLase PiQo4 – NaturaLase Nd:YAG 1064 Q
Switched Laser with 532 KTP Optics and Pulse Slicing
Module |
|----------------------|---------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | NaturaLase Nd:YAG 1064 QS Laser |
| Classification: | Class II |
| Regulation Number: | 878.4810 |
| Product Code: | GEX |
| Classification Name: | Powered Laser Surgical Instrument |
| Review Panel: | General & Plastic Surgery |
| Predicate Devices: | K142372 – PicoWay Laser System, Candela Corp. |
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III. Device Description:
The NaturaLase PiQo4 laser is a Nd:YAG 1064 Q-Switched laser with 532 KTP Optics and Pulse Slicing Module. The 532 KTP Optics is available to convert the basic 1064 nm wavelength to 532 nm and the pulse slicing electro-optics allows diverting the leading and trailing portions of the laser pulse away from the delivery system for the purpose of shortening the pulse duration without reducing the peak power.
The NaturaLase PiO04 laser offers fast and efficient treatment of tattoos and benign pigmented lesions removal through a variety of spot sizes, fluences and repetition rates. The laser energy is delivered via an articulated arm with interchangeable hand-pieces. A liquid crystal display (LCD) provides visual feedback of control settings and operating parameters. The mechanism of action for tattoo or pigmented lesion removal lies in delivering laser energy at very high peak power.
IV. Indication for Use:
NaturaLase PiQo4 – The NaturaLase Nd: YAG 1064 Q-switched Laser with 532 KTP Optics and Pulse Slicing Module - is indicated for use in aesthetic applications at the specified wavelength:
532 mm - removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
1064 nm - Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat tattoo colors: black, brown, green, blue and purple
V. Technological Characteristics:
The NaturaLase PiO04 laser has the same intended use and similar indications for use, technological characteristics and operating principles as the Candela PicoWay Laser System (K142372). The NaturaLase PiQo4 laser design and components are very similar to those of the predicate devices. They all have treatment handpieces connected to the articulated arm that is connected to the main console where the user interface is located. They all allow the spot size to be adjusted with the handpiece depending on the application. They all provide an aiming beam to assist in delivery of the therapeutic energy. Differences between the NaturaLase PiQ04 laser and predicate device in specific maximum energy levels and fluence delivered do not raise any new safety or effectiveness issues because the NaturaLase PiQo4 laser parameters fall within the range of parameters delivered by the predicate device.
VI. Testing Performance
All performance testing demonstrated that the NaturaLase PiQo4 laser performs according to specifications and functions as intended.
Electrical safety and electromagnetic compatibility (EMC) testing for the NaturaLase PiQ04 laser system was conducted by an independent laboratory in accordance with IEC 60601-1, Medical electrical equipment, part 1: general requirements for basic safety and essential performance. The NaturaLase PiQo4 laser was determined to be in conformance with applicable IEC standards (IEC 62366, 60601-1, 60601-1-6, 60601-2-22, and IEC 60825-1). The
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biocompatibility of the NaruraLase PiQo4 laser is consistent with the ISO 10993. Software verification and validation testing results are acceptable for software release.
VII. Summary of Substantial Equivalence
| | NaturaLase PiQo4 Laser (Focus
Medical) | | PicoWay
(Candela, Corp) | |
|-----------------|-------------------------------------------|-----------------------|----------------------------|-----------------------|
| Wavelength | 1064 nm | 532 nm | 1064 nm | 532 nm |
| Pulse Duration | 500 ps | 500 ps | 450 ps | 400 ps |
| Pulse Energy | 400 mJ | 200 mJ | 400 mJ | 200 mJ |
| Pulse Fluence | 1.4 J/cm2 @ 6 mm spot | 1.4 J/cm2 @ 4 mm spot | 1.4 J/cm2 @ 6 mm spot | 1.4 J/cm2 @ 4 mm spot |
| Peak Power | 800 MW | 400 MW | 889 MW | 500 MW |
| Peak Irradiance | 2.8GW/cm2 @ 6 mm spot | 2.8GW/cm2 @ 4 mm spot | 3.1GW/cm2 @ 6 mm spot | 3.5GW/cm2 @ 4 mm spot |
Review of the technological characteristics for the primary predicate device and the PiQo4 Laser shows close similarity in parameters principally responsible for generating tissue effects.
The NaturaLase PiQo4 laser has the same intended use as the predicate device with similar indications for use. It presents similar technological characteristics as the predicate device including the laser type, wavelengths, device design, pulse width, frequency, spot sizes and system components. Although there are some differences between the NaturaLase PiQ04 laser and its predicate device in terms of maximum pulse energy, fluence, pulse duration, etc. these differences do not present any new concerns of safety and effectiveness since the NaturaLase PiQo4 laser parameters are within the range used by the predicate devices for treatment of pigmented lesions and tattoo removal. The NaturaLase PiQo4 laser and its predicate device operate with the same mechanism of action based on selective photothermolysis and based on photothermal and significant photomechanical or acoustic effects of pigments in tattoos. Therefore, the NaturaLase PiQo4 laser has the same intended use and similar indications for use, technological characteristics, and principles of operation as predicate device. The NaturaLase PiQo4 laser is substantially equivalent to the predicate device.