Lumenis M22 System

K142860 · Lumenis, Ltd. · GEX · Jan 21, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K142860
• Device Name: Lumenis M22 System
• Applicant: Lumenis, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 21, 2015
• Decision: SESE
• Submission Type: Traditional
• 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 multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: 1. The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 8 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) 2. The Nd: Y AG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd: Y AG) 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 3. ResurFX module and handpiece, with wavelength of 1565 pm, is indicated for: · Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue 4. The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for: - Removal of dark tattoos · Treatment of pigmented lesions

Device Story

Multi-application aesthetic/dermatological platform; utilizes four interchangeable handpieces: IPL (400-1200nm), Multi-Spot Nd:YAG (1064nm), ResurFX (1565nm), and Q-Switched Nd:YAG (1064nm). Inputs: electrical energy converted to light/laser pulses. Operation: physician-controlled delivery of light/laser energy to target tissues (melanin, hemoglobin, water) for coagulation, resurfacing, or hair reduction. Used in clinical settings. Output: thermal/photomechanical tissue effects. Benefits: non-invasive treatment of skin conditions, vascular lesions, and hair reduction.

Clinical Evidence

Bench testing only. Safety and efficacy established via comparison to cleared predicate devices and existing scientific research/clinical studies for identical handpiece technologies.

Technological Characteristics

Multi-technology platform; IPL (400-1200nm), Nd:YAG (1064nm), ResurFX (1565nm). Xenon flash-lamp pumped solid state Nd:YAG. Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 60601-2-57.

Indications for Use

Indicated for aesthetic and dermatological procedures including treatment of benign epidermal/cutaneous lesions, vascular lesions, unwanted hair reduction (skin types I-V), inflammatory acne, soft tissue coagulation, skin resurfacing, and tattoo removal. Contraindications not specified.

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

• Lumenis Lum One (K060448)
• Lumenis LUME 2 (K083733)
• Lumenis ResurFX laser Module (K130028)
• Lumenis Quantum Q switched Nd:YAG (K043173)
• Palomar Lux V (K040081)
• Candela Nd:YAG laser System (K063074)

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

January 21, 2015

Lumenis Limited Ms. Elissa Burg Director of Quality Assurance/Quality Systems 6 Hakidma Street Yokneam 20692 Israel

Re: K142860 Trade/Device Name: Lumenis M22 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 22, 2014 Received: December 24, 2014

Dear Ms. Burg:

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

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# David Krause -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) K142860

Device Name

Lumenis M22™ System

#### 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:

1. The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 8 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)

2. The Nd: Y AG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd: Y AG) 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

3. ResurFX module and handpiece, with wavelength of 1565 pm, is indicated for:

· Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue

4. 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 the 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.

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

X 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 it, followed by the word "Lumenis" in blue. Below the word "Lumenis" is the phrase "Energy to Healthcare" also in blue. The logo is clean and modern, and the colors are bright and inviting.

# Section 2- 510(k) Summary

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Image /page/5/Picture/0 description: The image shows the Lumenis logo. The logo features a blue circle with a white "L" inside on the left. To the right of the circle is the word "Lumenis" in blue, with the tagline "Energy to Healthcare" underneath in a smaller font. The logo is clean and modern, with a focus on the company name and its mission.

### 510(K) SUMMARY

Lumenis M22 System

## 510(k) Number K

Applicant Name: Lumenis Ltd. 6 Hakidma Street, P.O.B. # 240 Yokneam 2069204 Israel Tel. [phone] Fax: [phone]

Contact Person: Elissa Burg Director of Regulatory Affairs & Quality Systems Telephone: [phone] Fax: [phone] E-mail: [e-mail]

Trade Name: Lumenis M22TM System

Summarv

Preparation Date: October 13, 2014

- Classification: Name: Intense Pulsed Light & Laser System and delivery devices Product Code: GEX, ONF, ONG Regulation No: 21 CFR 878.4810 Class: II Classification Panel: General and Plastic Surgery

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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 (K083733) .
- Multi-Spot Nd:YAG laser handpiece (K083733)
- ResurFX non-ablative laser handpiece (K130028) .
- Q-Switched Nd: Y AG laser handpiece (K043173) ●

#### Intended Use Statement:

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:

#### 1. The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 8 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)

#### 2. 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

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Image /page/7/Picture/0 description: The image shows the Lumenis logo. The logo consists of a blue circle with a white "L" inside it, followed by the word "Lumenis" in blue. Below the word "Lumenis" is the phrase "Energy to Healthcare" in a smaller blue font.

- 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
- 3. ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for:
- Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue
- The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm 4. is indicated for:
- Removal of dark tattoos ●
- Treatment of pigmented lesions

#### *Note

Permanent hair reduction is defined as the 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.

#### Predicate Devices:

Substantial equivalence to the following predicate devices is claimed:

| Device Name | 510k No | Date of Clearance |
|--------------------------------------|---------|-------------------|
| Lumenis Lum One | K060448 | July 5, 2006 |
| Lumenis LUME 2 | K083733 | May 04, 2009 |
| Lumenis ResurFX laser<br>Module | K130028 | Sep 03, 2013 |
| Lumenis Quantum Q<br>switched Nd:YAG | K043173 | Jan 1, 2005 |
| Palomar Lux V | K040081 | April 1, 2004 |
| Candela Nd:YAG laser<br>System | K063074 | Dec 27, 2006 |

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Image /page/8/Picture/0 description: The image shows the Lumenis logo. On the left is a blue circle with a white "L" inside. To the right of the circle is the word "Lumenis" in blue, with the registered trademark symbol in the upper right corner. Below the word "Lumenis" is the phrase "Energy to Healthcare" in a smaller blue font.

#### Substantial Equivalence to Predicate Devices

The subject Lumenis M22 System's IPL handpiece uses a spectrum of 400-1200 mm, combined by filters used in Lumenis One (K060448), Lumenis LUME 2 (K083733) and Palomar LuxV (K040081). The device contains filters for different parts of this spectrum, same as the predicates. The minor differences in technical specifications do not raise any new questions of safety and efficacy.

Lumenis M22 System also has the Acne filter (Notch filter 400-600 & 800-1.200 nm) for the treatment of inflammatory Acne vulgaris which is similar to the Palomar Lux V (K040081) Acne filter which has a wavelength of 400-700 nm & 870-1200 nm. The minor differences in the wavelengths do not raise any new questions of safety and efficacy.

The subject Lumenis M22 system's Multi-Spot Nd:YAG handpiece uses a 1064nm laser, which is equivalent to the handpiece used by its predicate device: Lumenis Lume 2 (K083733). Both products use a Xenon flash-lamp pumped solid state Nd:YAG, and both utilize the same pulse rate and similar performance characteristics. The Lumenis M22 Nd:YAG laser has an additional tip of 1.5 mm, which has similar characteristics as the predicate device of Candela Nd:YAG laser system (K063074).

The subject Lumenis M22 System's ResurFX handpiece is the same as the ResurFX handpiece that was cleared under K130028 and used with the market cleared Lumenis Lume 2 (K083733), being the case for all their physical parameters as well as their intended uses.

The subject Lumenis M22 System's Q-Switched handpiece is equivalent to the Q-Switched handpiece that has been used with the market cleared Lumenis Quantum (K043173). The only differences are a minor increase in fluence (<10%), caused by the specification of the Nd:YAG rods and an additional 6mm metal tip.

2-5

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Image /page/9/Picture/0 description: The image shows the Lumenis logo. The logo consists of a blue circle with a white "L" inside it, followed by the word "Lumenis" in blue text. Below the word "Lumenis" is the phrase "Energy to Healthcare" in smaller blue text.

#### Performance Standards:

The subject Lumenis M22 System complies with

- . IEC 60601-1: 2005 Medical Electrical Equipment-Part 1: General Requirements for Safety. Collateral Standard: Safety Requirements for Medical Electrical Systems.
● IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.

IEC 60601-2-22:2007 - Medical electrical equipment - Part 2-22: ● Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.

. IEC 60825-1:2007 - Safety of laser products - Part 1: Equipment classification, and requirements.

● IEC 60601-2-57:2011 - Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetics.

#### Performance Bench Tests

Bench testing demonstrated that the subject Lumenis M22 System is as safe and effective as the cleared predicate devices.

#### Summary of Pre-Clinical and Clinical Study

The safety and efficacy of all the identified handpieces applied within the subject Lumenis M22 System are well established in scientific research and clinical studies. Multiple studies with these and similar systems have shown safety in aesthetic and dermatological procedures, in addition to the devices cleared for marketing by the FDA.