NaturaLase CO2 laser operating in tractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.

Device Description

The NaturaLase CO2 is an RF excited CO2 laser. The main console of the NaturaLase CO2 laser system contains the following components:

CO2 laser tube
Power Supply
Optical bench assembly
Articulated Arm
Hand-pieces: scanning and surgical
Touch screen controller/user interface

The laser source is a sealed CO2 laser tube that is mounted vertically within the main cabinet and the laser beam is passed from the laser tube into the articulated arm. The NaturaLase CO2 laser unit is equipped with a switching-mode power supply, which converts the input line voltage to the high voltage required for laser operation. The optical bench assembly consists of the articulated arm mount, the aiming beam diode laser (3mW @ 650nm) and optics to align the laser beam and the aiming beam to the articulated arm. The laser energy is delivered through an articulated arm to a hand-piece (scanner or surgical) that distributes the laser energy on the target in a controlled and uniformed way. The user-interface microprocessor-based touch screen allows operator to control all operating functions.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "NaturaLase CO2 Laser System." This document aims to demonstrate the substantial equivalence of the new device to previously cleared predicate devices, rather than proving its performance against specific acceptance criteria for a new clinical indication or a new type of device requiring complex performance studies (like AI/ML-driven diagnostic devices).

Therefore, many of the typical acceptance criteria and study elements listed in your request (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, ground truth types for training data) are not applicable to this type of regulatory submission. This document focuses on showing that the NaturaLase CO2 Laser System operates similarly to predicate devices and does not introduce new questions of safety or effectiveness.

Here's how to address your request based on the provided document:

Acceptance Criteria and Device Performance

For a device like the NaturaLase CO2 Laser System seeking 510(k) clearance, the primary "acceptance criterion" is demonstrating substantial equivalence to existing predicate devices. This is achieved by showing that the new device has the same intended use and technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

The document demonstrates this through:

Comparison of Technical Specifications: The core method of proving substantial equivalence is through direct comparison of the new device's technical specifications and operating principles with those of the predicate devices.
Performance Testing (Bench Testing): The document refers to engineering verification and validation tests to ensure the device performs according to its own specifications and functions as intended, and conforms to relevant safety standards. This is not clinical performance testing against a disease state, but rather engineering and safety performance.

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" here are implicitly the parameters of the predicate devices a new device must match or fall within to demonstrate substantial equivalence, alongside compliance with relevant safety standards. The "reported device performance" are the specifications of the NaturaLase CO2 Laser System.

Criterion (Predicate Device Parameter Range / Safety Standard)	NaturaLase CO2 Laser System Performance (Acceptance)
Intended Use	Same as Predicate Devices
Laser Type (CO2 Laser)	CO2 Laser (Matches Predicate)
Wavelength (10.6 μm)	10.6 μm (Matches Predicate)
Power (Up to 30 W)	Up to 30 W (Matches Predicate)
Pulse Width (Fraction) (0.2-20 ms; 0.2-10 ms)	0.2-10 ms (Falls within Predicate Range)
Pulse Width (Surgical) (0.5-80 ms; .2 to 10ms)	.2 to 10ms (Falls within Predicate Range)
Spot Size (Fraction) (120 and 300 μm; 300 μm)	120 and 300 μm (Matches Predicate)
Spot Size (Surgical) (200, 400, 1000 μm; 300 μm)	300 μm (Matches Predicate)
Energy Emission (Pulse/single pulse/cw)	Pulse/single pulse/cw (Matches Predicate)
Energy to tissue (10-45 mJ per micro spot)	10-45 mJ per micro spot (Matches Predicate)
Peak Power (60 W)	60 W (Matches Predicate)
Aiming beam (<4 mW @ 650 nm; 3 mW @ 650 nm)	3 mW @ 650 nm (Matches Predicate)
Articulated Arm (7-mirrors; 7-joint spring-balanced)	7-joint spring-balanced (Matches Predicate)
Electrical Safety & EMC Compliance (IEC 60601-1, IEC 62366, 60601-1-6, 60601-2-22, IEC 60825-1)	Conforming (as stated in document)
Biocompatibility Compliance (ISO 10993)	Consistent with ISO 10993 (as stated in document)
Software Verification & Validation	Acceptable for software release (as stated in document)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable for clinical test sets as this is a 510(k) based on substantial equivalence to existing devices, not a new clinical performance claim requiring patient data. The "testing performance" section refers to engineering and safety performance testing (bench testing), not testing on a patient sample.
Data Provenance: Not applicable for clinical data. The testing was likely conducted at the manufacturer's facility or an independent laboratory (as stated for electrical safety and EMC testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for clinical outcomes is not established in this type of submission. The "ground truth" here is adherence to engineering specifications and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication pertains to expert review of clinical data, which was not part of this submission for substantial equivalence.

5. 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

Not applicable. This is not an AI/ML diagnostic device. It's a laser surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML diagnostic device with a "standalone algorithm."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the established technical specifications and safety standards (e.g., IEC standards, ISO standards) that medical devices of this type are expected to meet, and the performance parameters of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of machine learning for this device. The development process relied on established engineering principles and prior knowledge from predicate devices.

9. How the ground truth for the training set was established

Not applicable. No machine learning training set or associated ground truth. The "ground truth" for device design and verification comes from engineering principles, industry standards, and the validated performance of predicate devices.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 4, 2016

Focus Medical, LLC % Michail Pankratov Principal MMP Medical Associates LLC 16 Appleton Street Waltham, Massachusetts 02453

Re: K152529

Trade/Device Name: Naturalase Co2 Laser System 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. ONG Dated: January 7, 2016 Received: January 8, 2016

Dear Michail 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 CFR

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Part 807); labeling (21 CFR Part 801); medical device 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.

Sincerely yours,

Jennifer R. Stevenson -S

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

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Indications for Use

510(k) Number (if known)

Device Name NaturaLase CO2 Laser System

Indications for Use (Describe)

NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.

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:	August 26, 2015

II. Device Information

Trade Name:	NaturaLase CO2 Laser System
Common/Usual Name:	CO2 Laser System
Classification:	Class II
Regulation Number:	878.4810
Product Code:	GEX; ONG
Classification Name:	Powered Laser Surgical Instrument
Review Panel:	General & Plastic Surgery
Predicate Devices:	K110333 - NaturaLase CO2 Laser System, FocusMedicalLLC; K123573 – YOULASER CO2 Laser System, QuantaSystem S.P.A.

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III. Device Description:

The NaturaLase CO2 is an RF excited CO2 laser. The main console of the NaturaLase CO2 laser system contains the following components:

CO2 laser tube
Power Supply
Optical bench assembly
Articulated Arm
Hand-pieces: scanning and surgical
Touch screen controller/user interface

IV. Indication for Use:

NaturaLase CO2 laser operating in traditional non-fractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, urology, neurosurgery, dental and oral surgery and genitourinary surgery. NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.

V. Technological Characteristics:

The NaturaLase CO2 laser technical specifications are very similar to the predicate devices. All have the same intended use, technological characteristics and operating principles as the previously cleared NaturaLase CO2 Laser system (K110333) and Quanta System YOULASER Laser System (K123573). The NaturaLase CO2 laser design and components are very similar to those of the predicate devices. Their treatment handpieces connected to the articulated arm that is connected to the main console where the user interface is located. Differences between the NaturaLase CO2 laser and predicate devices in specific maximum energy levels and fluence delivered do not raise any new safety or effectiveness issues because the NaturaLase CO2 laser parameters fall within the range of parameters delivered by the predicate devices.

VI. Testing Performance

All performance testing demonstrated that the NaturaLase CO2 laser performs according to specifications and functions as intended. The NaturaLase CO2 laser system was determined to be in conformance with all applicable standards. Electrical safety and electromagnetic compatibility (EMC) testing for the NaturaLase CO2 laser system was conducted by an independent laboratory

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in accordance with IEC 60601-1. Medical electrical equipment, part 1: general requirements for basic safety and essential performance. The NaturaLase CO2 laser was determined to be in conformance with applicable IEC standards (IEC 62366, 60601-1-6, 60601-1-6, 60601-2-22, and IEC 60825-1). The biocompatibility of the NaruraLase CO2 laser is consistent with the ISO 10993.

Software verification and validation testing results are acceptable for software release.

VII. Summary of Substantial Equivalence

Review of the technological characteristics for the primary predicate device and the NaturaLase CO2 Laser shows close similarity in parameters principally for generating tissue effects (see Table below).

The NaturaLase CO2 laser has the same intended use as the predicate devices with similar indications for use. It presents similar technological characteristics as the predicate devices including the laser type, wavelengths, device design, pulse width, frequency, spot sizes and system components. Few differences between the NaturaLase CO2 laser and its predicate devices in terms of maximum pulse energy, fluence, pulse duration, etc, do not present any new concerns of safety and effectiveness. The NaturaLase CO2 laser and its predicates all operate with the same mechanism of action based on selective photothermolysis. Therefore, the NaturaLase CO2 laser has the same intended use and similar indications for use, technological characteristics, and principles of operation as predicate devices. The NaturaLase CO2 laser is substantially equivalent to the predicate devices.

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510(k)		K123573	K110333
Manufacturer		Quanta System S.P.A	Focus Medical LLC	Focus Medical LLC
Device Name		YOULASER CO2 Laser	NaturaLase CO2	NaturaLase CO2
DeviceClassificationName		Powered Laser SurgicalInstrument	Powered Laser SurgicalInstrumentMicrobeam/Fractional Output	Powered Laser SurgicalInstrumentMicrobeam/Fractional Output
Regulation Number		878.4810	878.4810	878.4810
Product Code		GEX	ONG	GEX, ONG
Laser Source		CO2	CO2	CO2
Wavelength		10.6 μm	10.6 μm	10.6 μm
Power		Up to 30 W	Up to 30 W	Up to 30 W
Pulsewidth	Fraction	0.2 - 20 ms	0.2-10 ms	0.2-10 ms
	Surgical	0.5 – 80 ms	-	.2 to 10ms
Spot Size	Fraction	300 μm	120 and 300 μm	120 and 300 μm
	Surgical	200, 400, 1000 μm		300 μm
Energy Emission		Pulse/single pulse/cw	Pulse/single pulse/cw	Pulse/single pulse/cw
Energy to tissue			10-45 mJ per micro spot	10-45 mJ per micro spot
Peak power			60 W	60 W
Aiming beam		<4 mW @ 650 nm	3 mW @ 650 nm	3 mW @ 650 nm
Articulated arm		7-mirrors	7-joint spring-balanced	7-joint spring-balanced
Electric Power		230 VAC?50-60 Hz	110VAC/60 Hz or 220 VAC/50 Hz	110VAC/60 Hz or 220 VAC/50 Hz
Dimensions		48x55x120 cm	34x46x126 cm	34x46x126 cm
Weight		30 Kg	35 Kg	35 Kg
Indications for use		YOULASER CO2 laser when used in traditional non-fractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical	The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue, additionally, the	NATURALASE CO2 laser operating in traditional non-fractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical

TABLE - Comparison of the NaturaLase CO2 with the Predicate Devices

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specialties including aesthetic(dermatology and plastic surgery),otolaryngology(ENT),gynecology,neurosurgery, dental and oralsurgery and genitourinary surgery.YOULASER CO2 laser whenused in fractional mode (dotscanner) is indicated for ablativeskin resurfacing	fractional spot sizes are used in thetreatment of wrinkles; rhytides,furrows, fine lines, texturalirregularities, pigmented lesionsand vasculardyschromia.	specialties including aesthetic(dermatology and plastic surgery),otolaryngology(ENT),urology,neurosurgery, dental and oral surgeryand genitourinary surgery.NATURALASE CO2 laseroperating in fractional mode isindicated for ablative skinresurfacing.
Device DescriptionThe YOULASER CO2 LaserSystem includes a single modelnamed YOULASER CO2 emittinga maximum power of30 Watt at 10.6 µm. TheYOULASER CO2 Lasercomposed externally of metallicshell with a frontal polyurethanepanel containing the touch screendisplay. On this panel the keyswitch, emergency red push buttonand the operation led are insertedtoo. On the rear panel thefootswitch connector, the remoteinterlock, the power switch arelocated. The system is composedof power supply, CO2 laser sourcewith air cooling system, opticalbench, articulated arm with CO2scanner, the control electronics.The electronic, based on amicrocontroller, manages thevoltage power supply and the CO2laser source.	The NaturaLase CO2 is an RFexcited CO2 laser. The laser energyis delivered through an articulatedarm and with a scanner, thatdistributes the laser energy on theskin in a controlled way withuniform distribution. The scannerdesign allows the system to ablatesmall micro spots of tissue. Thesystem has the ability to delivermicro spots with a size of 120microns and up to 45 mJ of opticalenergy per micro spot.The NaturaLase CO2 laser systemconsists of-CO2 laser tube,-Power supply,-Closed loop cooling system,- user interface control- an articulated arm- a scanning hand piece- a traditional hand piece	The NaturaLase CO2 is an RFexcited CO2 laser. The laser energyis delivered through an articulatedarm and with a scanner, thatdistributes the laser energy on theskin in a controlled way withuniform distribution. The scannerdesign allows the system to ablatesmall micro spots of tissue. Thesystem has the ability to delivermicro spots with a size of 120microns and up to 45 mJ of opticalenergy per micro spot.The NaturaLase CO2 laser systemconsists of-CO2 laser tube,-Power supply,-Closed loop cooling system,- user interface control- an articulated arm- a scanning hand piece- a traditional hand piece

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.