M22 and ResurFx Systems

K170060 · Lumenis, Ltd. · GEX · Aug 9, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170060
• Device Name: M22 and ResurFx Systems
• Applicant: Lumenis, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 9, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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 Story

M22 and ResurFX are multi-application aesthetic platforms using IPL, Nd:YAG laser, and Er:Glass fiber laser technologies. Systems deliver light/laser energy to skin via interchangeable handpieces; IPL uses cut-off/notch filters (400-1200nm); Nd:YAG (1064nm) targets vascular lesions/hair; ResurFX (1565nm) performs fractional resurfacing. Operated by clinicians in dermatological/aesthetic settings. AOPT (Advanced Optimal Pulse Technology) allows tailored pulse sequencing. Output includes thermal coagulation/ablation of target tissues. Benefits include hair reduction, lesion clearance, and skin resurfacing. System includes software presets and scanning shapes (line, rectangle, etc.) to assist user control. Output affects clinical decision-making by enabling precise, customized treatment of dermatological conditions.

Clinical Evidence

Bench testing only. Testing included risk analysis (ISO 14971), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and non-laser light source safety (IEC 60601-2-57). Verification and validation confirmed software updates, new handpiece accessories, and scanning shapes perform as intended within specifications.

Technological Characteristics

Multi-technology platform (IPL, Nd:YAG, Er:Glass fiber laser). IPL: 400-1200nm, sapphire cooling. Nd:YAG: 1064nm. ResurFX: 1565nm, dual-axis scanner. Connectivity: Standalone. Sterilization: N/A (non-invasive/external). Software: Presets and AOPT mode. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57.

Indications for Use

Indicated for aesthetic and dermatological skin procedures including benign epidermal/cutaneous lesions, vascular lesions, unwanted hair reduction (skin types I-V), inflammatory acne, coagulation/hemostasis of vascular lesions/soft tissue, non-ablative facial wrinkle treatment, fractional skin resurfacing, and tattoo/pigmented lesion removal.

Regulatory Classification

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.

Predicate Devices

• M22 System (K142860)
• ResurFX module (K130028)

Reference Devices

• Lumenis 510(k) (K020839)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 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.

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)

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### 510(k) SUMMARY

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

| Applicant Name: | Lumenis Ltd.<br>6 Hakidma Street PO Box 240<br>Yokneam Industrial Park,<br>Yokneam 2069204, Israel<br>Tel: [phone]<br>Fax: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Naama Jacoby - Head of RA, Ophthalmic & M22 Platforms<br>6 Hakidma Street PO Box 240<br>Yokneam Industrial Park,<br>Yokneam 2069204, Israel<br>Tel: [phone]<br>Fax: [phone]<br>Mail: [e-mail] |
| Date Prepared: | August 07, 2017 |
| Trade Name: | Lumenis Family of IPL and Laser Systems:<br>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 K142860<br>ResurFX module, cleared under K130028 |
| Indications for Use: | The complete phrasing of the indications for use statement for the<br>Lumenis Family of IPL and Laser Systems, combining both the M22<br>and ResurFX Systems, is provided in the formal Indications for Use<br>Statement (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.

| Device<br>Feature | Lumenis M22 System (K142860)<br>(Predicate Device) | Lumenis M22 System (K170060)<br>(Subject Device) |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IPL Handpiece<br>Wavelength | 400 -1200 nm | Same |
| Pulse Duration (msec) | Up to 20 msec - single pulse<br>40-100 msec - multiple pulse | Same |
| Operational Wavelengths | The IPL handpiece comes with 8 filters<br>for various wavelengths:<br>Cut-off filters: 515, 560, 590, 615, 640,<br>695, 755 nm<br>Acne Filter (Notch filter 400-600 and<br>800-1200 nm) | The IPL handpiece comes with 10 filters<br>for various wavelengths:<br>Cut-off filters: 515, 560, 590, 615, 640,<br>695, 755 nm<br>Acne Filter (Notch filter 400-600 and<br>800-1200 nm)<br>Vascular Filter (Notch filter 530-650 &<br>900-1200 nm)<br>KTP filter (525-585 nm) |
| Spot sizes (cm²) | • 8 mm x 15 mm<br>• 15 mm x 35 mm | • 8mm x 15 mm<br>• 15 mm x 35 mm<br>• 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 Sequential<br>Pulsing | 1, 2 and 3 pulses | 1, 2 and 3 pulses, varying fluence per<br>pulse (AOPT mode) |
| Multi-Spot Nd:YAG Handpiece<br>Operational 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 Sequential<br>Pulsing | 1, 2 and 3 pulses | Same |
| ResurFX Handpiece<br>Operational 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 Tip<br>18 mm Precision Tip |
| Scanner | Dual axis scanner | Same |
| Scanning shapes | Line, square, rectangle, circle,<br>donut, hexagon | Line, square, rectangle, circle, donut,<br>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 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.

### 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)<br>(Predicate Devices) | ResurFX System (Subject)<br>(Subject Device) |
|----------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Operational<br>Wavelengths | 1565nm | Same |
| Max Energy | up to 70mJ per micro- beam | up to 40 or 70mJ per micro- beam, upon<br>tip |
| Type of laser | Er:Glass Fiber-laser with scanner | Same |
| Tips | SapphireCool | SapphireCool, Precision |
| Spot size, mm | 5-18 | Same |
| Tip treatment<br>width | 18mm | Same |
| Scanner | Dual axis scanner | Same |
| Scanning shapes | Line, square, rectangle, circle,<br>donut, hexagon | Line, square, rectangle, circle,<br>donut, hexagon, vertical line and vertical<br>rectangle |
| 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.