NaturaLase PiQo4 - The NaturaLase Nd: Y AG 1064 Q-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.

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (NaturaLase PiQo4 laser). It details the device's characteristics and its equivalence to a predicate device but does not describe a clinical study or acceptance criteria related to device performance in a clinical setting.

Instead, the "Testing Performance" section refers to engineering and safety performance testing. Therefore, I cannot extract the information required for the requested table and study details.

Here's how to interpret the available information:

Acceptance Criteria and Reported Device Performance: This section would typically involve clinical metrics like success rates, adverse event rates, or specific measurements related to the intended clinical effect. The document does not provide this. The "Testing Performance" section mentions compliance with safety and electrical standards (IEC 60601-1, IEC 62366, 60601-1-6, 60601-2-22, IEC 60825-1) and biocompatibility (ISO 10993), as well as software verification and validation. These are engineering/safety criteria, not clinical performance criteria.

Therefore, most of your requested points cannot be answered from the provided text.

Here's a breakdown of what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Clinical)	Reported Device Performance (Clinical)
Not specified in the document	Not specified in the document
Acceptance Criteria (Engineering/Safety)	Reported Device Performance (Engineering/Safety)
Compliance with IEC 60601-1 (medical electrical equipment, basic safety & essential performance)	Determined to be in conformance with IEC 60601-1
Compliance with IEC 62366 (usability)	Determined to be in conformance with IEC 62366
Compliance with IEC 60601-1-6 (usability)	Determined to be in conformance with IEC 60601-1-6
Compliance with IEC 60601-2-22 (surgical lasers)	Determined to be in conformance with IEC 60601-2-22
Compliance with IEC 60825-1 (laser safety of products)	Determined to be in conformance with IEC 60825-1
Biocompatibility consistent with ISO 10993	Biocompatibility is consistent with ISO 10993
Acceptable software verification and validation	Software verification and validation results are acceptable for software release
Functional performance according to specifications	Performs according to specifications and functions as intended

Study Details:

The provided text does not describe a clinical study to prove the device meets clinical acceptance criteria. The "Testing Performance" section refers to engineering and safety testing, not clinical efficacy or effectiveness.

Therefore, the following cannot be answered from the provided document:

Sample size used for the test set and the data provenance: N/A (No clinical test set described)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A
Adjudication method for the test set: N/A
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (This device is a laser, not an AI diagnostic tool involving human readers)
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an algorithm)
The type of ground truth used: N/A
The sample size for the training set: N/A
How the ground truth for the training set was established: N/A

Conclusion:

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (PicoWay Laser System, K142372) based on similar intended use, indications for use, technological characteristics, and safety testing. It explicitly states that "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."

This type of 510(k) submission typically relies on non-clinical performance data (like electrical safety, EMC, biocompatibility, and functional testing) and a comparison to a predicate device's established safety and effectiveness, rather than requiring a dedicated clinical study from the applicant to prove clinical acceptance criteria.

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

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.

192

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) SUMMARY

As required by section 21 CFR 807.92

I. General Information

Applicant:	Focus Medical, LLC2 Francis J Clarke CircleBethel, CT 06801TEL: 203-730-8885FAX: 203-730-8851
Contact Person:	Michail M. Pankratov, MD, PhDMMP Regulatory Consultants, LLC16 Appleton StreetWaltham, MA 02453TEL: 617-480-4543clregconsult@aol.com
Preparation Date:	July 28, 2015

II. Device Information

Trade Name:	NaturaLase PiQo4 – NaturaLase Nd:YAG 1064 QSwitched Laser with 532 KTP Optics and Pulse SlicingModule
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.

{4}------------------------------------------------

III. Device Description:

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

{5}------------------------------------------------

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 (FocusMedical)		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.

Regulation Number and Section

§ 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.