(85 days)
The InMode VLaze is intended for the treatment of vascular lesions, including angiomas, telangiestasia, port wine stains, leg veins and other benign vascular lesions.
The InMode VLaze device is designed to deliver diode laser energy to the skin via a pre-cooled sapphire block. The good optical contact between the sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The hand piece has integrated skin cooling to enhance safety and comfort of the treatment. The InMode VLaze device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises the InMode VLaze device laser with linear scanning system, cooled sapphire output window (3 x 4mm2), and electronic shutter. The sapphire light guide is located on the front tip of the hand piece and delivers the laser beam energy to the treated tissue, while cooling the skin. The pair of thermoelectric coolers (TECs) located on both sides of the sapphire block provide cooling to a temperature of 7°C. The hand piece contains a trigger button which starts the laser scan and radiation. Fluence is delivered within the limits of 40 to 300J/cm². The hand piece has a cable that is 170cm long and connects the hand piece to the console via a connector.
The provided text describes the InMode VLaze laser surgical instrument and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI assistance.
Instead, the document focuses on:
- Regulatory Compliance: Demonstrating that the device adheres to recognized voluntary performance standards for medical electrical equipment and laser product safety (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
- Substantial Equivalence: Arguing that the InMode VLaze device is substantially equivalent to previously cleared predicate devices (Lumenis Ltd. ET Lightsheer 1060, Quanta System SPA EVO Platform, and InMode MD Ltd. InMode Diolaze XL) based on its intended use, design, components, performance specifications (wavelength, fluence, pulse width, cooling), and safety features.
The document explicitly states under "Clinical Performance Data": "Not Applicable". This means no clinical study with human subjects was conducted to evaluate the device's efficacy or performance in terms of treatment outcomes for vascular lesions for this 510(k) submission. Therefore, it's not possible to extract the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these pertain to clinical or AI/algorithm performance evaluation, which was not part of this specific submission.
Summary of what can be extracted from the provided text:
- Device Performance (as per non-clinical testing): The device was tested for compliance with electrical and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22). The "Non-Clinical Performance Data" section states, "The test results show that the device performance specifications meet the system requirements."
- No Clinical Study Details: The document explicitly states "Clinical Performance Data: Not Applicable." This means no clinical study measuring treatment effectiveness or outcomes was submitted or is detailed.
Therefore, based on the provided text, the following information cannot be provided:
- A table of acceptance criteria and reported device performance related to clinical efficacy or diagnostic accuracy.
- Sample sizes used for a test set for clinical performance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or effect size of human readers with/without AI assistance.
- If a standalone algorithm performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical evaluation.
- Sample size for a training set (as no AI/algorithm is detailed).
- How ground truth for a training set was established.
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February 23, 2018
InMode MD Ltd. % Amit Goren Regulatory Manager A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata' as Str., Suite 102 Kfar Saba, 44425 Il
Re: K173677
Trade/Device Name: InMode VLaze 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 Dated: November 27, 2017 Received: November 30, 2017
Dear Amit Goren:
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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -ਟਤੋ 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)
Device Name InMode VLaze
Indications for Use (Describe)
The InMode VLaze is intended for the treatment of vascular lesions, including angiomas, telangiestasia, port wine stains, leg veins and other benign vascular lesions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY INMODE VLAZE DEVICE 510(k) Number K173677
Applicant Name:
| Company Name: | InMode MD Ltd. |
|---|---|
| Address: | Tabor Building, Shaar YokneamYokneam 2069200Israel |
| Tel: +972-4-9097470 | |
| Fax: +972-4-9097471 | |
| E-mail: amit@asteinrac.com |
Contact Person:
| Official Correspondent: | Amit Goren |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102Kfar Saba 4442500Israel |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: amit@asteinrac.com | |
| Date Prepared: | February 4, 2018 |
| Trade Name: | InMode VLaze Device |
| Classification Name: | CFR Classification section 878.4810; (Product code GEX) |
| Classification: | Class II Medical Device |
Predicate Device:
The InMode VLaze device is substantially equivalent to the following predicate devices.
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Lumenis Ltd. | ET Lightsheer 1060 | K133319 |
| Quanta System SPA | EVO Platform | K160368 |
| InMode MD Ltd. | InMode Diolaze XL | K170738 |
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Device Description:
The InMode VLaze device is designed to deliver diode laser energy to the skin via a pre-cooled sapphire block. The good optical contact between the sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The hand piece has integrated skin cooling to enhance safety and comfort of the treatment.
The InMode VLaze device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises the InMode VLaze device laser with linear scanning system, cooled sapphire output window (3 x 4mm2), and electronic shutter.
The sapphire light guide is located on the front tip of the hand piece and delivers the laser beam energy to the treated tissue, while cooling the skin. The pair of thermoelectric coolers (TECs) located on both sides of the sapphire block provide cooling to a temperature of 7°C. The hand piece contains a trigger button which starts the laser scan and radiation. Fluence is delivered within the limits of 40 to 300J/cm². The hand piece has a cable that is 170cm long and connects the hand piece to the console via a connector.
InMode VLaze Device Specifications:
| Wavelengths | 1060nm ± 15nm |
|---|---|
| Fluence | 40 - 300 J/cm² |
| Pulse width (duration) | 5-100msec |
| Light guide cooling | Strong :7°C, Normal:12 °C |
| Spot size | 3mm x 4mm |
| Dimension | 46cm W x 46cm D x 100cm H(18.2" W x 18.2" D x 40" H) |
| Weight | 32 Kg (70.548 lbs) |
| Main Line Frequency (nominal) | 50-60 Hz |
| Input Voltage (nominal) | 100-240 VAC |
Intended Use/Indication for Use:
The InMode VLaze is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
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Performance Standards:
The InMode VLaze device was tested and complies with the voluntary performance standards listed below:
- IEC 60601-1: 2005 (Third Edition) + CORR.1 2006 + CORR.2 2007 + A1:2012 . Medical Electrical Equipment - Part 1: General Requirements for Safety.
- IEC 60601-1-2, 2007 (Third Edition), Medical Electrical Equipment Part 1-2: . General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests
- IEC 60825-1:2007 (Second Edition) Safety of laser products, Part 1: . Equipment classification and requirements.
- IEC 60601-2-22:2007 (Third Edition) + A1:2012 for use in conjunction with ● IEC 60601-1:2005 (Third Edition) + A1:2012 - Medical Electrical Equipment -Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
Non-Clinical Performance Data:
The device laser performance specifications and system requirements were evaluated as part of the compliance tests to the IEC 60601-1, IEC 60601-2-22 and IEC 60825-1 standard requirements. The test results show that the device performance specifications meet the system requirements.
Clinical Performance Data:
Not Applicable
Substantial Equivalence:
The indications for use of the InMode VLaze device are substantially equivalent to the indications for use of the ET Lightsheer 1060 and of the EVO platform predicate devices. The design and components in the InMode VLaze device, including the console (with power supply, software, cooling system and touch screen user interface), the water-cooled hand piece (with cable and connector to console) and the foot switch are based on to the design and components found in the InMode Diolaze XL (same platform system) and are similar to the ET Lightsheer 1060 and EVO platform predicate devices. The performance specifications (including wavelength, pulse width, pulse repetition rate, spot size and cooling temperature) in the InMode VLaze device are similar to performance specifications of the ET Lightsheer 1060 and EVO platform predicate devices. The safety features in the InMode VLaze device are substantially equivalent to the safety features found in the predicate devices. Consequently, the InMode VLaze device is substantially equivalent to the ET Lightsheer 1060 predicate device cleared in 510(k) K133319, to the EVO platform predicate device, cleared in 510(k) K160368 and to the InMode Diolaze XL predicate device, cleared in 510(k) K170738and therefore, may be legally marketed in the USA.
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Conclusions:
Based on the performance testing and comparison to predicate devices, the InMode
VLaze device is substantially equivalent to the predicate devices listed above.
§ 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.