The subject Lumenis M22 System has connection capability with the following available treatment handpieces, for multiapplication treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 10 different filters) is indicated for:

Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos
Cutaneous lesions, including warts, scars and striae
Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations
Removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
Mild to moderate inflammatory Acne (Acne vulgaris)
The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg
The removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
The non-ablative treatment of facial wrinkles
ResurFX module and handpiece. with wavelength of 1565 nm. is indicated for:
Use in dermatological procedures requiring fractional skin resurfacing and coaqulation of soft tissue
The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for:
Removal of dark tattoos
Treatment of pigmented lesions
*Note Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The ResurFX System with wavelength of 1565 nm. is indicated for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

Device Description

The subject Lumenis M22 System is a multi-application, multi-technology platform with four (4) available treatment handpieces:

Universal Intense Pulsed Light (IPL) handpiece:
Multi-Spot Nd:YAG laser handpiece;
ResurFX non-ablative laser handpiece;
Q-Switched Nd:YAG laser handpiece.
The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the M22 System:
The Universal IPL handpiece has ten (10) different filters available: Cut-off filters of 515, 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530-650 & 900-1200 nm, and a Narrow band filter of 525-585 nm. Further, the IPL handpiece has three (3) sapphire cool light guides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6mm diameter.
The Multi-Spot Nd:YAG handpiece has four (4) different light guides/tips available in sizes of: 2mm x 4mm, 6 mm, 9 mm and 1.5 mm.
The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips.
The Q-Switched Nd: YAG handpiece has both disposable and gold plated metal treatment tips available. The disposable treatment tips are available in four (4) different sizes of: 2, 2.5, 3.5, and 5 mm. The metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

The ResurFX System is an advanced computer-controlled laser emission system operating at a wavelength of 1565 nm, and is intended for Fractional Non-Ablative Skin Resurfacing application when using a dedicated handpiece.
The following accessories are provided with and/or may be purchased independently for the ResurFX System:

Two (2) different treatment tips: SapphireCool and Precision tips.
Footswitch.

AI/ML Overview

The provided document is a 510(k) summary for the Lumenis M22 and ResurFX Systems, which are laser surgical instruments. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through studies involving human-in-the-loop or standalone algorithm performance.

Therefore, many of the requested details about acceptance criteria, study types, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory document. This document details engineering and performance bench testing to ensure the modified device functions as intended and safely, similar to its predicate.

Here's an analysis of the information that can be extracted from the document:

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

The document doesn't present a table of specific clinical acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the performance bench testing ensuring the device meets safety and operational standards and functions as intended, similar to the predicate devices. The "reported device performance" is essentially that it passed these engineering and safety tests.

Device Feature/Aspect	Acceptance Criteria (Implied)	Reported Device Performance
IPL Handpiece
Wavelength	Same as predicate (400-1200 nm)	Same (400-1200 nm)
Pulse Duration (msec)	Same as predicate	Same
Operational Wavelengths (Filters)	Addition of new filters (Vascular Filter, KTP filter) without compromising safety/efficacy	Integrated new filters, functioning as intended
Spot sizes (cm²)	Addition of new 6mm round size without compromising safety/efficacy	Integrated new 6mm round size, functioning as intended
Max Fluence	Up to 35 J/cm², or 56 J/cm² supported by K020839 for tip size	Up to 35 or 56 J/cm², upon tip size; expected fluence with new filters/guides showed lower fluence than previously cleared devices.
Pulse Rate [Hz]	Same as predicate (Up to 1 Hz)	Same
Multiple Sequential Pulsing	Addition of AOPT mode with varying fluence per pulse, without compromising safety/efficacy	AOPT mode integrated, functioning as intended
Multi-Spot Nd:YAG Handpiece
Operational Wavelengths	Same as predicate (1064 nm)	Same
Spot sizes (mm)	Same as predicate	Same
Max Fluence	Same as predicate (Up to 600 J/cm²)	Same
Pulse Rate [Hz]	Same as predicate (Up to 1 Hz)	Same
Multiple Sequential Pulsing	Same as predicate	Same
ResurFX Handpiece (M22 System & Standalone)
Operational Wavelengths	Same as predicate (1565nm)	Same
Max Energy	Up to 70mJ per micro-beam; or up to 40mJ supported for new tip	Up to 40 or 70mJ per micro-beam, upon tip; expected fluence with new scan shapes/Precision tip showed same or lower fluence than previously cleared devices.
Type of laser	Same as predicate (Er:Glass Fiber-laser with scanner)	Same
Tip treatment width	Addition of 18mm Precision Tip	Integrated new 18mm Precision Tip, functioning as intended
Scanning shapes	Addition of "vertical line" and "vertical rectangle" without compromising safety/efficacy	Integrated new scanning shapes, functioning as intended
Scanner	Same as predicate (Dual axis scanner)	Same
Q-Switched Nd:YAG Handpiece
Operational Wavelengths	Same as predicate (1064 nm)	Same
Spot sizes (mm, diameter)	Addition of 4mm and 8mm sizes without compromising safety/efficacy	Integrated new 4mm and 8mm sizes, functioning as intended; expected fluence with new tips showed lower fluence than previously cleared device.
Max Fluence	Same as predicate (Up to 14 J/cm²)	Same
Pulse Duration(nsec)	Same as predicate (6-8)	Same
Pulse Rate [Hz]	Same as predicate (0.5-5.0)	Same
General
Risk Analysis	Compliance with ISO 14971	Performed
Electrical Safety & EMC	Conformance with IEC 60601-1, IEC 60601-1-2	Passed
IPL Compatibility	Conformance with IEC 60601-2-57	Passed
Software Changes	Validated to work as intended	Validated
Handpiece Accessories/Features	Validated to work as intended	Validated
ResurFX Environmental Testing	Ability to withstand variant operation, storage, and transportation conditions	Passed

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

Not applicable. This is a 510(k) for a device modification, focusing on engineering verification and validation (V&V) and safety testing. There is no "test set" in the context of clinical data for an AI algorithm. The V&V activities involve testing the physical device and its components.

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. No "ground truth" was established by clinical experts for a test set, as this is not a study of an AI or diagnostic device's clinical performance.

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

Not applicable. No clinical test set requiring adjudication was used.

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 document is not about an AI-assisted diagnostic device, but rather a laser surgical instrument. Therefore, no MRMC study was conducted or reported.

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

Not applicable. This device does not have a standalone algorithm in the sense of a diagnostic or image interpretation AI. Its "standalone" characteristic refers to the ResurFX system being made available as a separate unit rather than just a module of the M22. This is a hardware device for treatment, not an algorithm for analysis.

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

Not applicable. The ground truth for this device's performance is its physical and electrical specifications, and its ability to function safely and effectively within those parameters as demonstrated by engineering bench testing and compliance with recognized standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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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, stacked on top of each other.

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

August 9, 2017

Lumenis, Ltd. Naama Jacoby Head Of RA Ophthalmic & M22 Platforms 6 Hakidma Street Po Box 240 Yokneam, 2069204 IL

Re: K170060

Trade/Device Name: M22 And Resurfx Systems 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, ONF, ONG Dated: August 7, 2017 Received: July 17, 2017

Dear Naama Jacoby:

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

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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 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.

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

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510(k) Number (if known)

K170060

Device Name

Lumenis Family of IPL and Laser Systems: M22 and ResurFx Systems

Indications for Use (Describe)

The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 10 different filters) is indicated for: .

Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos .
. Cutaneous lesions, including warts, scars and striae
Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, . erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations
. Removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
Mild to moderate inflammatory Acne (Acne vulgaris) .
The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for: ●
- The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of . superficial and deep telangiectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg
- . The removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- . The non-ablative treatment of facial wrinkles
ResurFX module and handpiece. with wavelength of 1565 nm. is indicated for: .
- Use in dermatological procedures requiring fractional skin resurfacing and coaqulation of soft tissue .
The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for: .
- . Removal of dark tattoos
- . Treatment of pigmented lesions

*Note

Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The ResurFX System with wavelength of 1565 nm. is indicated for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

Type of Use (Select one or both, as applicable)

図 Prescription Use (Part 21 CFR 801 Subpart D)

□Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image shows the Lumenis logo. The logo consists of a blue circle with a white "L" inside, followed by the word "Lumenis" in blue. Below the word "Lumenis" is the tagline "Energy to Healthcare" also in blue.

510(k) SUMMARY

Lumenis Family of IPL and Laser Systems: M22 & ResurFX Systems

Applicant Name:	Lumenis Ltd.6 Hakidma Street PO Box 240Yokneam Industrial Park,Yokneam 2069204, IsraelTel: +972-4-9599000Fax: +972-4-9599046
Contact Person:	Naama Jacoby - Head of RA, Ophthalmic & M22 Platforms6 Hakidma Street PO Box 240Yokneam Industrial Park,Yokneam 2069204, IsraelTel: +972-4-9599085Fax: +972-4-9599198Mail: Naama.Jacoby@lumenis.com
Date Prepared:	August 07, 2017
Trade Name:	Lumenis Family of IPL and Laser Systems:M22 & ResurFX Systems
Classification Name:	Powered laser surgical instrument
Product Code:	GEX, ONF, ONG
Device Class:	Class II
Regulation Number:	21 CFR 878.4810
Panel:	General & Plastic Surgery
Predicate Device:	M22 System, cleared under K142860ResurFX module, cleared under K130028
Indications for Use:	The complete phrasing of the indications for use statement for theLumenis Family of IPL and Laser Systems, combining both the M22and ResurFX Systems, is provided in the formal Indications for UseStatement (FDA Form 3881)

From this point on, the 510(k) summary addresses the M22 System and the ResurFX System separately as follows:

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M22 System

Indications for Use:

The subject Lumenis M22 System has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:

· The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 10 different filters) is indicated for:
- -Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos
- Cutaneous lesions, including warts, scars and striae
- -Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
- -Removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- Mild to moderate inflammatory Acne (Acne vulgaris) -
The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for:
- -The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg
- The removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- -The non-ablative treatment of facial wrinkles
· ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for:
- -Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
The O-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for:
- -Removal of dark tattoos
- Treatment of pigmented lesions l

*Note: Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

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Device Description:

The subject Lumenis M22 System is a multi-application, multi-technology platform with four (4) available treatment handpieces:

-Universal Intense Pulsed Light (IPL) handpiece:
। Multi-Spot Nd:YAG laser handpiece;
। ResurFX non-ablative laser handpiece;
-Q-Switched Nd:YAG laser handpiece.

The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the M22 System:

। The Universal IPL handpiece has ten (10) different filters available: Cut-off filters of 515, 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530-650 & 900-1200 nm, and a Narrow band filter of 525-585 nm. Further, the IPL handpiece has three (3) sapphire cool light guides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6mm diameter.
The Multi-Spot Nd:YAG handpiece has four (4) different light guides/tips available in sizes of: 2mm x 4mm, 6 mm, 9 mm and 1.5 mm.
-The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips.
। The Q-Switched Nd: YAG handpiece has both disposable and gold plated metal treatment tips available. The disposable treatment tips are available in four (4) different sizes of: 2, 2.5, 3.5, and 5 mm. The metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

Technological Characteristics and Substantial Equivalence:

The intended use and indications for use of the M22 System are the selected predicate devices. In addition, the same technological characteristics and principles of operation apply for the M22 System and the predicate device.

The Lumenis M22 System main modification that have been made are:

Addition of the IPL AOPT (Advanced Optimal Pulse Technology) Operation Mode that । assists the physician in specifically tailoring the treatment to the patient's needs.
Addition of new accessories to the IPL Handpiece a Vascular Filter and a KTP filter. ।
Addition of a new 6mm diameter light guide to the IPL Handpiece ।
Addition of 4mm and 8 mm tips to the Q-switched Nd: YAG handpiece. ।
। Addition of a new 18mm Precision tip to the ResurFX handpiece.

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Addition of scanning shapes to the ResurFX handpiece Vertical line and rectangle. ।
Additional Lumenis software presets for user convenience. -
-Software Upgrade to support the specified modifications.

These modifications have been introduced in order to configure a system that improves user convenience or increase their control of the delivered treatment.

Comparison table of technological characteristics of the Lumenis M22 System compared to those of the predicate device is provided below. The new accessories and features are bolded.

DeviceFeature	Lumenis M22 System (K142860)(Predicate Device)	Lumenis M22 System (K170060)(Subject Device)
IPL HandpieceWavelength	400 -1200 nm	Same
Pulse Duration (msec)	Up to 20 msec - single pulse40-100 msec - multiple pulse	Same
Operational Wavelengths	The IPL handpiece comes with 8 filtersfor various wavelengths:Cut-off filters: 515, 560, 590, 615, 640,695, 755 nmAcne Filter (Notch filter 400-600 and800-1200 nm)	The IPL handpiece comes with 10 filtersfor various wavelengths:Cut-off filters: 515, 560, 590, 615, 640,695, 755 nmAcne Filter (Notch filter 400-600 and800-1200 nm)Vascular Filter (Notch filter 530-650 &900-1200 nm)KTP filter (525-585 nm)
Spot sizes (cm²)	• 8 mm x 15 mm• 15 mm x 35 mm	• 8mm x 15 mm• 15 mm x 35 mm• 6 mm round
Max Fluence	Up to 35 J/cm²	Up to 35 or 56 J/cm², upon tip size
Pulse Rate [Hz]	Up to 1 Hz	Same
Multiple SequentialPulsing	1, 2 and 3 pulses	1, 2 and 3 pulses, varying fluence perpulse (AOPT mode)
Multi-Spot Nd:YAG HandpieceOperational Wavelengths	1064 nm	Same
Spot sizes (mm)	2 x 4, 1.5, 6, 9	Same
Max Fluence	Up to 600 J/cm², upon tip size	Same
Pulse Rate [Hz]	Up to 1 Hz	Same
Multiple SequentialPulsing	1, 2 and 3 pulses	Same
ResurFX HandpieceOperational Wavelengths	1565nm	Same
Max Energy	up to 70mJ per micro- beam	up to 40 or 70mJ per micro- beam, upon tip
Type of laser	Er:Glass Fiber-laser with scanner	Same
Tip treatment width	18mm SapphireCool Tip	18 mm SapphireCool Tip18 mm Precision Tip
Scanner	Dual axis scanner	Same
Scanning shapes	Line, square, rectangle, circle,donut, hexagon	Line, square, rectangle, circle, donut,hexagon, vertical line and vertical
Device	Lumenis M22 System (K142860)	Lumenis M22 System (K170060)
Feature	(Predicate Device)	(Subject Device)
		rectangle
Q-Switched Nd:YAG Handpiece
Operational Wavelengths	1064 nm	Same
Spot sizes (mm, diameter)	2, 2.5, 3.5, 5, 6	2, 2.5, 3.5, 4, 5, 6, 8
Max Fluence	Up to 14 J/cm², upon tip size	Up to 14 J/cm², upon tip size
Pulse Duration(nsec)	6-8	Same
Pulse Rate [Hz]	0.5-5.0	Same

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Substantial Equivalent Discussion:

The physical components of the M22 System and handpieces were unchanged compared to the legally marketed predicate device. The handpieces remain unchanged, except for the addition of several accessories and features.

The IPL Handpiece accessories that have been added have the same wavelength, pulse rate, use of sequential pulsing, and use of sapphire cooling. The expected fluence with use of the additional filters and light guides showed lower fluence than that of previously cleared devices. The higher 56J/cm² is supported by Lumenis 510(k) number K020839.

The Q-Switched Nd: Y AG Handpiece two new treatment tips sizes have the same wavelength, pulse rate, pulse duration, and maximum fluence. The expected fluence with use of new tips showed lower fluence than that of the previously cleared device.

The ResurFX Handpiece addition of various treatment shapes and the new Precision Tip have the same wavelength, max energy per pulse and treatment tip width.

All features of the predicate and subject device were validated to work as intended within V&V activities.

Performance Bench Testing:

Performance testing was conducted in order to demonstrate the performance of the M22 System and its substantial equivalence, with respect to the safety and effectiveness of the cleared predicate device. The following activities were performed:

Risk analysis activities in compliance with the requirements of ISO 14971.
. Electrical safety and electromagnetic compatibility testing as required to conform with the following performance standards:
- । IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- । IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - requirements and tests.

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IPL compatibility testing as required to conform with the following performance ● standard:
- । IEC 60601-2-57 Medical Electrical Equipment - Part 2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment.
Verification and validation testing: ●
- All software changes have been validated to work as intended. |
- -The Handpiece accessories and features that have been added were validated.

Conclusions:

Test results indicated that the subject M22 System performs in accordance with its requirements and specifications, in similarity to its predicate device. Consequently, the M22 System was found to perform as well as its predicate, to be as safe and effective for its intended use as its predicate, and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues.

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ResurFX System

Indications for Use:

The ResurFX System with wavelength of 1565 nm. is indicated for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

Device Description:

The following accessories are provided with and/or may be purchased independently for the ResurFX System:

-Two (2) different treatment tips: SapphireCool and Precision tips.
। Footswitch.

Technological Characteristics and Substantial Equivalence:

This ResurFX module (K130028, K142860) was modified to be a standalone system to provide an additional member of the growing product family to meet customer needs.

The intended use and indications for use of the ResurFX System are the selected predicate devices. In addition, the same technological characteristics and principles of operation apply for the ResurFX System and the predicate devices.

Comparison table of technological characteristics of the Lumenis ResurFX System compared to those of the predicate devices is provided below. The new accessories and features are bolded.

	ResurFX Module (K130028, K142860)(Predicate Devices)	ResurFX System (Subject)(Subject Device)
OperationalWavelengths	1565nm	Same
Max Energy	up to 70mJ per micro- beam	up to 40 or 70mJ per micro- beam, upontip
Type of laser	Er:Glass Fiber-laser with scanner	Same
Tips	SapphireCool	SapphireCool, Precision
Spot size, mm	5-18	Same
Tip treatmentwidth	18mm	Same
Scanner	Dual axis scanner	Same
Scanning shapes	Line, square, rectangle, circle,donut, hexagon	Line, square, rectangle, circle,donut, hexagon, vertical line and verticalrectangle
Input Power	100-240 VAC 12Amax, 50/60Hz	100-240 VAC, 3A, 50/60 Hz

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Substantial Equivalent Discussion:

The standalone ResurFX module was modified to be a standalone system. The ResurFX handpieces remain unchanged, except for the addition of an accessory and feature.

The ResurFX Handpiece addition of various treatment scanning shapes and the new Precision Tip have the same wavelength, max energy per pulse, and treatment tip width.

All features of the predicate and subject device were validated to work as intended within V & V activities.

Performance Bench Testing:

Performance testing was conducted in order to demonstrate the performance of the ResurFX System and its substantial equivalence, with respect to the safety and effectiveness of the cleared predicate devices. The following activities were performed:

Risk analysis activities in compliance with the requirements of ISO 14971. ●
Electrical safety and electromagnetic compatibility testing as required to conform with . the following performance standards:
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic । safety and essential performance.
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for । basic safety and essential performance- Collateral standard: Electromagnetic compatibility - requirements and tests.
Verification and validation testing: ●
- All software changes have been validated to work as intended. |
- The ResurFX Handpiece added treatment shapes and the Precision Tip were । validated. The wavelength, max energy per pulse, type of laser, and treatment tip width remain unchanged. The expected fluence with use of the new scan shapes and Precision tip showed same or lower fluence than that of previously cleared devices.
Environmental testing demonstrating the ability of the subject device to withstand variant . operation, storage and transportation conditions.

Conclusions:

Test results indicated that the subject ResurFX System performs in accordance with its requirements and specifications, in similarity to its predicate devices. Consequently, the ResurFX System was found to perform as well as its predicates, to be as safe and effective for its intended use as its predicate, and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues.

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.