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 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)

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

ResurFX module and handpiece, with wavelength of 1565 pm, 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 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.

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) ●

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Lumenis M22 System:

This document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to predicate devices, rather than providing detailed acceptance criteria and standalone study reports for the new device itself. Therefore, much of the requested information (e.g., specific acceptance criteria values, performance metrics against those criteria, detailed study design for a new device, number of experts for ground truth, adjudication methods, MRMC study results, training set details) is not present in this document.

The document primarily relies on the established safety and efficacy of its predicate devices and the fact that its components are either identical or very similar to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, this document does not present specific quantitative acceptance criteria or a table of performance metrics for the Lumenis M22 against such criteria. The "Performance Bench Tests" section generally states: "Bench testing demonstrated that the subject Lumenis M22 System is as safe and effective as the cleared predicate devices," but no specific numerical results or targets are provided.

2. Sample size used for the test set and the data provenance

Test set sample size: Not specified. The document states that the safety and efficacy are "well established in scientific research and clinical studies" using "these and similar systems," implying reliance on existing literature and prior clearances rather than a new standalone test set for the M22 system itself.
Data provenance: Not specified. Given the reliance on existing literature and predicate devices, the provenance would be diverse from those prior studies. The document does not indicate new prospective or retrospective data for the M22 system's clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not specified. Due to the nature of the 510(k) submission, which relies on equivalence and existing data, there's no mention of a new panel of experts establishing ground truth specifically for the M22 system's performance.
Qualifications of experts: Not specified.

4. Adjudication method for the test set

Adjudication method: Not specified.

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

MRMC study: No. This device is a laser/light system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. Therefore, an MRMC study and AI-related effect size are not applicable or mentioned.

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

Standalone performance study: The document refers to "Bench testing" and "Summary of Pre-Clinical and Clinical Study" indicating that "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." This suggests reliance on existing data and prior clearances. It does not describe a new, standalone performance study specifically for the M22 system itself as part of this submission, beyond demonstrating that its components function similarly to predicates.

7. The type of ground truth used

Type of ground truth: Not explicitly stated for a new study. For the predicate devices and existing scientific literature, ground truth would typically be based on:
- Clinical outcomes: observable reduction in lesions, hair, or wrinkles.
- Expert assessment: dermatologists or other aesthetic practitioners assessing treatment success.
- Histopathology: in some cases, for confirmation of lesion types (though less common for aesthetic treatments).

8. The sample size for the training set

Training set sample size: Not applicable. This is a physical device, not an AI algorithm that requires a training set.

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

Ground truth for training set: Not applicable (see point 8).

Summary of what is available in the document regarding "proof":

The "proof" for the Lumenis M22 System primarily relies on substantial equivalence to predicate devices.

Device Components: The M22 System integrates multiple handpieces, each of which is described as being identical or very similar to components of previously FDA-cleared devices (Lumenis Lum One, Lumenis LUME 2, Lumenis ResurFX, Lumenis Quantum, Palomar Lux V, Candela Nd:YAG laser system).
Minor Differences: Any minor technical differences (e.g., slight fluence increase, additional tip size, minor wavelength differences in filters) are explicitly stated "do not raise any new questions of safety and efficacy."
Performance Bench Tests: It states that "Bench testing demonstrated that the subject Lumenis M22 System is as safe and effective as the cleared predicate devices," but no details of these tests or specific results are provided.
Clinical Efficacy and Safety: The document claims, "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." This relies on the existing body of evidence supporting the predicate devices and their technologies.
Compliance with Standards: The device complies with relevant IEC standards (60601-1, 60601-1-2, 60601-2-22, 60825-1, 60601-2-57) pertaining to medical electrical equipment safety, electromagnetic compatibility, and laser/light source equipment. This demonstrates engineering and electrical safety.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, with three overlapping profiles facing to the right.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

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

• 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: Y AG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd: Y AG) is indicated for:

· 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 pm, 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 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. (972) 4-959-9000 Fax: (972) 4-959-9050

Contact Person: Elissa Burg Director of Regulatory Affairs & Quality Systems Telephone: (972) 4-959-9000 Fax: (972) 4-959-9050 E-mail: Elissa.Burg@lumenis.com

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:

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
1. 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 laserModule	K130028	Sep 03, 2013
Lumenis Quantum Qswitched Nd:YAG	K043173	Jan 1, 2005
Palomar Lux V	K040081	April 1, 2004
Candela Nd:YAG laserSystem	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.

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.