(112 days)
Not Found
No
The document describes a multi-technology laser and IPL system for dermatological procedures. There is no mention of AI or ML in the intended use, device description, or performance studies summary. The focus is on the physical properties of the light and laser technologies.
Yes
The device is indicated for the treatment of various medical conditions such as benign epidermal lesions, vascular lesions, acne, and cutaneous lesions, which falls under the definition of therapeutic use.
No
The document describes the device as a multi-application, multi-technology platform with various handpieces for aesthetic and dermatological skin procedures, such as treating benign epidermal lesions, vascular lesions, and hair removal. Its intended uses are therapeutic, not diagnostic.
No
The device description clearly states it is a "multi-application, multi-technology platform with four (4) available treatment handpieces," which are physical hardware components (IPL, Nd:YAG, ResurFX, Q-Switched Nd:YAG). This is not a software-only device.
Based on the provided information, the Lumenis M22 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed for "aesthetic and dermatological skin procedure applications." These procedures involve treating the skin directly for various conditions and cosmetic purposes.
- Device Description: The device description details different handpieces that use light and laser technology to interact with the skin.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. The Lumenis M22 System does not perform this function. It is a therapeutic device that applies energy to the body.
Therefore, the Lumenis M22 System is a therapeutic device used for dermatological and aesthetic treatments, not an IVD.
N/A
Intended Use / 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 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
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONF, ONG
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) ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Bench testing demonstrated that the subject Lumenis M22 System is as safe and effective as the cleared predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K060448, K083733, K130028, K043173, K040081, K063074
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
· 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.
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:
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
-
- 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 | ||
| Module | K130028 | Sep 03, 2013 |
| Lumenis Quantum Q | ||
| switched Nd:YAG | K043173 | Jan 1, 2005 |
| Palomar Lux V | K040081 | April 1, 2004 |
| Candela Nd:YAG laser | ||
| 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 (