Stellar M22 for Intense Pulsed Light (IPL) and Laser System

K193500 · Lumenis, Ltd. · GEX · Jan 16, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K193500
• Device Name: Stellar M22 for Intense Pulsed Light (IPL) and Laser System
• Applicant: Lumenis, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 16, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lumenis Stellar M22 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 Stellar Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for: - Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles) - Cutaneous lesions, including warts, scars and striae - Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations - Removal of unwanted hair 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 table 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 Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for: - Removal of dark tattoos - Treatment of pigmented lesions

Device Story

Multi-application platform using selective photothermolysis for aesthetic/dermatological procedures. Inputs: user-selected treatment parameters via console. Outputs: IPL (400-1200nm), Nd:YAG laser (1064nm), or Er:Glass fiber-laser (1565nm) energy delivered via handpieces. Used in clinical settings by trained professionals. Device features sapphire cooling, scanner-assisted fractional resurfacing, and multiple sequential pulsing (AOPT). Output affects tissue via thermal coagulation/hemostasis or melanin targeting. Benefits include hair reduction, lesion clearance, and skin resurfacing. System includes lightguide recognition and remote access for internal company use.

Clinical Evidence

Bench testing only. Evidence includes design verification/validation, risk analysis (ISO 14971), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), IPL compatibility (IEC 60601-2-57), and software verification/validation.

Technological Characteristics

Multi-application platform; energy sources: IPL (400-1200nm), Nd:YAG laser (1064nm), Er:Glass fiber-laser (1565nm). Features sapphire cooling, dual-axis scanner, and lightguide recognition. Connectivity: Windows 10 Embedded OS, remote access capability. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57.

Indications for Use

Indicated for aesthetic/dermatological procedures including benign epidermal/cutaneous lesions, dyschromia, hyperpigmentation, melasma, ephelides, warts, scars, striae, vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, poikiloderma, venous malformations), unwanted hair reduction (skin types I-V), inflammatory acne, coagulation/hemostasis of vascular/soft tissue, facial wrinkles, tattoo removal, and pigmented lesions.

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 (K170060)

Submission Summary (Full Text)

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Lumenis Ltd. % Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004

Re: K193500

Trade/Device Name: Stellar M22 for Intense Pulsed Light (IPL) and 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, ONF, ONG Dated: December 17, 2019 Received: December 17, 2019

Dear Jonathan Kahan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for

combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jessica Mavadia-Shukla Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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| Indications for Use Statement | |
|-------------------------------|--|
|-------------------------------|--|

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

| Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement on last page |
|---------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------|

| 510(k) Number (if known) | K193500 |
|--------------------------------|-------------------------------------------------------------|
| Device Name | Stellar M22 for Intense Pulsed Light (IPL) and Laser system |
| Indications for Use (Describe) | |

The subject Stellar M22 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 400-1200 nm (with 9 different filters) is indicated for:
- Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and o ephelides (freckles)
- Cutaneous lesions, including warts, scars and striae O
- Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, O truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
- Removal of unwanted hair and to effect stable long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
- Mild to moderate inflammatory Acne (Acne vulgaris) o
- 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 O 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 and to effect table long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
- The non-ablative treatment of facial wrinkles o
- . ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for:
- Use in dermatological procedures requiring fractional skin resurfacing and O

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coagulation of soft tissue

#### The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated ● for:

- Removal of dark tattoos O
- o 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 completion of treatment regime.

C)

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart

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# 510(k) SUMMARY

# Stellar M22 for Intense Pulsed Light (IPL) and Laser System

### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam Industrial Park Yokneam 2069204, Israel

Phone: [phone] Facsimile: [phone]

Contact Person: Shlomit Segman, RA Senior Manager

Date Prepared: December 17, 2019

### Name of the device:

Stellar M22 for Intense Pulsed Light (IPL) and Laser system

### Classification Name:

Powered Laser Surgical Instrument

### Regulation Class:

Class II

# Product Code:

GEX (21 C.F.R. § 878.4810)

#### Subsequent Product Codes:

ONF, ONG

#### Predicate Device:

M22 System (K170060)

#### Intended Use

The Lumenis Stellar M22 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:

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- The Stellar Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:
- Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and o ephelides (freckles)
- Cutaneous lesions, including warts, scars and striae O
- Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, O truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
- Removal of unwanted hair and to effect stable long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
- Mild to moderate inflammatory Acne (Acne vulgaris) o
- 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 O 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 table long term, or o permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
- The non-ablative treatment of facial wrinkles o
- ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for: ●
- Use in dermatological procedures requiring fractional skin resurfacing and o coagulation of soft tissue
- . The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for:
- Removal of dark tattoos O
- Treatment of pigmented lesions o

*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 completion of treatment regime.

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# Device Description

The subject Stellar M22 for Intense Pulsed Light (IPL) and Laser System is a multi-application, multitechnology platform with four (4) available treatment handpieces:

- Stellar 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 Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems:

- The Stellar IPL handpiece has nine (9) 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. Further, the IPL handpiece has three (3) Sapphire Cool LightGuides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6 mm diameter.
- The Multi-Spot Nd:YAG handpiece has three (3) different LightGuides available in sizes . of: 2mm x 4mm, 6 mm, and 9 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 and metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

### Technological Characteristics

The intended use and indications for use of the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems are the same as the predicate device. In addition, the same technological characteristics and principles of operation apply for the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems and the predicate device.

Comparison table of the technological characteristics of the Stellar M22 for Intense Pulsed Light (IPL) and Laser System compared to the predicate device is provided below:

| | Stellar M22<br>(subject device) | Cleared M22 and<br>ResurFX Systems<br>(K170060) | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Principle of Operation | Selective<br>photothermolysis | Selective<br>photothermolysis | Same as predicate |
| Device Components | System console<br>Four (4) available<br>treatment handpieces:<br>• Stellar Intense<br>Pulsed Light<br>(IPL) | System console<br>Four (4) available<br>treatment handpieces:<br>• Universal<br>Intense Pulsed<br>Light (IPL) | Same as predicate |
| Monitor Display | Multi-Spot<br>Nd:YAG laser<br>handpiece Q-Switched<br>Nd:YAG laser<br>handpiece ResurFX non-<br>ablative laser<br>module and<br>handpiece 12" | Multi-Spot<br>Nd:YAG laser<br>handpiece Q-Switched<br>Nd:YAG laser<br>handpiece ResurFX non-<br>ablative laser<br>module and<br>handpiece 8.4" | Substantially<br>equivalent |
| Software operating<br>system | Windows 10 Embedded | Windows CE 5 | Substantially<br>equivalent |
| IPL Handpiece | | | |
| Wavelength | 400-1200 nm | 400-1200 nm | Same as predicate |
| Pulse duration<br>(msec) | Up to 20 msec – single<br>pulse | Up to 20 msec – single<br>pulse | Same as predicate |
| Operational<br>wavelengths | The IPL handpiece<br>comes with 9 filters for<br>various wavelengths: Cut-off filters: 515,<br>560, 590, 615, 640,<br>695, 755 nm Acne Filter (Notch<br>filter 400-600 and<br>800-1200) Vascular Filter<br>(Notch filter 530-650<br>& 900-1200) | The IPL handpiece<br>comes with 10 filters for<br>various wavelengths: Cut-off filters: 515,<br>560, 590, 615, 640,<br>695, 755 nm Acne Filter (Notch<br>filter 400-600 and<br>800-1200) Vascular Filter<br>(Notch filter 530-650<br>& 900-1200) KTP filter (525-585<br>nm) | Same as predicate<br>but without the<br>KTP filter |
| SapphireCool<br>LightGuides | Height: 55 mm | Height: 40 mm | Substantially<br>equivalent – minor<br>modification to<br>dimension |
| Spot sizes (cm²) | 8x15 mm (1.20 cm2)<br>15x35 mm (5.25 cm2)<br>6 mm round (0.3 cm2) | 8x15 mm (1.20 cm2)<br>15x35 mm (5.25 cm2)<br>6 mm round (0.3 cm2) | Same as predicate |
| Maximum Fluence | Up to 35 or 56 J/cm²,<br>upon tip size | Up to 35 or 56 J/cm²,<br>upon tip size | Same as predicate |
| Pulse Rate [Hz] | Up to 1 Hz | Up to 1 Hz | Same as predicate |
| Multiple Sequential<br>Pulsing | Yes, 1, 2, and 3 pulses,<br>varying fluence per<br>pulse (AOPT mode) | Yes, 1, 2, and 3 pulses,<br>varying fluence per<br>pulse (AOPT mode) | Same as predicate |
| Contact sapphire<br>cooling temperature | 0 to10 °C (Rectangular)<br>0 to 15°C (Round) | 4 to 10°C | Substantially<br>Equivalent - |
| | | | |
| Treatment screens | Treatment present with<br>additional basic<br>treatment presets | Treatment present | Substantially<br>equivalent - Minor<br>software update to<br>platform |
| LightGuide<br>recognition | Yes | N/A | Substantially<br>Equivalent -<br>Addition of minor<br>Hardware and<br>software features<br>to recognize<br>connected fibers |
| Multi-Spot Nd:YAG Handpiece | | | |
| Operational<br>Wavelength | 1064 nm | 1064 nm | Same as predicate |
| Spot sizes (mm) | 2x4, 6, 9 | 2x4, 1.5, 6, 9 | Substantially<br>Equivalent |
| Maximum Fluence | Up to 225 J/cm² upon tip<br>size (due to removal of<br>the 1.5 mm tip) | Up to 600 J/cm² upon tip<br>size | Substantially<br>Equivalent |
| Pulse rate | Up to 1 Hz | Up to 1 Hz | Same as predicate |
| Multiple Sequential<br>Pulsing | 1, 2, and 3 | 1, 2, and 3 | Same as predicate |
| Contact sapphire<br>cooling temperature | -4 to 10 °C | 4 to 10°C | Substantially<br>Equivalent |
| ResurFX Handpiece | | | |
| Operational<br>Wavelength | 1565 nm | 1565 nm | Same as predicate |
| Maximum Energy | Up to 40 or 70 mJ per<br>micro-beam, upon tip | Up to 40 or 70 mJ per<br>micro-beam, upon tip | Same as predicate |
| Type of Laser | Er:Glass Fiber-laser with<br>scanner | Er:Glass Fiber-laser with<br>scanner | Same as predicate |
| Tip treatment width | 18 mm Sapphire Cool<br>Tip<br>18 mm Precision Tip | 18 mm Sapphire Cool<br>Tip<br>18 mm Precision Tip | Same as predicate |
| Scanner | Dual axis scanner | Dual axis scanner | Same as predicate |
| Scanner shapes | Line, square, rectangle,<br>circle, donut, hexagon,<br>vertical line, and vertical<br>rectangle | Line, square, rectangle,<br>circle, donut, hexagon,<br>vertical line, and vertical<br>rectangle | Same as predicate |
| Treatment screens | Treatment present with<br>additional basic<br>treatment presets | Treatment present | Substantially<br>equivalent - Minor<br>software update to<br>platform |
| Q-Switched Nd:YAG Handpiece | | | |
| Operational<br>Wavelength | 1064 nm | 1064 nm | Same as predicate |
| Spot sizes (mm, diameter) | Disposable tips: 2.0, 2.5, 3.5 and 5.0 mm<br>Gold plated metal tips:<br>2.0, 2.5, 3.5, 4.0, 5.0, 6.0 and 8.0 mm | Disposable tips: 2.0, 2.5, 3.5 and 5.0 mm<br>Gold plated metal tips:<br>2.0, 2.5, 3.5, 4.0, 5.0, 6.0 and 8.0 mm | Same as predicate |
| Maximum Fluence | Up to 14 J/cm², upon tip size | Up to 14 J/cm², upon tip size | Same as predicate |
| Pulse Duration (nsec) | 6-8 | 6-8 | Same as predicate |
| Pulse Rate (Hz) | 0.5-5.0 | 0.5-5.0 | Same as predicate |
| Software | | | |
| Remote access capabilities | Yes | N/A | Substantially<br>Equivalent -<br>Addition of minor<br>software features<br>for internal<br>company use |

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# Performance Data

The following tests were performed to validate the modifications to the device:

- Design verification and validation testing .
- Risk analysis activities in compliance with ISO 14971 ●
- Electrical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2
- . IPL compatibility testing as required to conform with IEC 60601-2-57
- . Software verification and validation

### Conclusions

Stellar M22 for Intense Pulsed Light (IPL) and Laser system has the same intended use and similar indications, principles of operation, and technological characteristics as M22 System. The minor differences in the Stellar M22 for Intense Pulsed Light (IPL) and Laser system's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the Stellar M22 for Intense Pulsed Light (IPL) and Laser system is as safe and effective as M22 System. Thus, the Stellar M22 for Intense Pulsed Light (IPL) and Laser system is substantially equivalent to its predicate devices.