(95 days)
No
The device description focuses on hardware components and basic control parameters (fluence, pulse duration). There is no mention of AI/ML terms, image processing for analysis, or any description of training or test data sets, which are typical indicators of AI/ML integration in medical devices.
No
The device is indicated for hair removal and permanent reduction in hair regrowth, which are generally considered cosmetic procedures rather than therapeutic interventions for treating diseases or conditions.
No.
The InMode Diolaze device is indicated for hair removal and permanent reduction in hair regrowth, which are treatment functions, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a power supply, diode driver, water cooling system, controller, user interface with LCD screen and buttons, a hand piece with a laser, scanning system, sapphire output window, and thermoelectric coolers. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Diolaze Function: The InMode Diolaze device is a laser device that delivers optical energy directly to the skin for hair removal. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is for hair removal and permanent reduction in hair regrowth, which is a cosmetic or therapeutic procedure performed directly on the patient's body.
The description clearly indicates a device that interacts directly with the patient's skin using laser energy, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The InMode Diolaze device is indicated for use for hair removal and for permanent reduction in hair regrowth, 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.
Product codes
GEX
Device Description
The InMode Diolaze device is designed to deliver optical energy to the skin via a precooled 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 scanning system embedded into the laser of the InMode Diolaze device hand piece allows efficient treatment with less risk of overlap. The hand piece has integrated skin cooling to enhance safety and comfort of the treatment.
The InMode Diolaze device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and user interface including an LCD screen and functional buttons. 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 Diolaze device laser with linear scanning system, cooled sapphire output window (8 x 50mm), 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 4°C. The hand piece contains a trigger button which starts the laser scan and radiation. Fluence (light energy density) is delivered within the limits of 10 to 60J/cm². The hand piece has a cable that is 170cm long and connects the hand piece to the console via a connector.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
The InMode Diolaze device is identical to the InMode Hair Removal (HR) device (same device), as such, for this 510k submission the same performance test documents used for K123682 are provided comparing the InMode Hair Removal (HR) device laser output parameters to those of the Leda EPI 808 predicate device. The results of the bench tests demonstrate that the InMode HR device has the same laser output specifications as the predicate Leda EPI 808 device and along with the fact that the InMode Diolaze device is identical to the InMode Hair Removal device, it can be concluded that the InMode Diolaze device is substantially equivalent to the predicate devices.
Clinical Performance Data:
Not Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2015
Inmode Md Ltd. % Ahava Stein Regulatory Manager A. Stein-Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 4442520 Israel
Re: K142952 Trade/Device Name: Inmode Diolaze Device 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 19, 2014 Received: November 24, 2014
Dear Ahava Stein.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. 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.
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 yours.
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
2
Indications for Use
510(k) Number (if known) K142952
Device Name InMode Diolaze Device
Indications for Use (Describe)
The InMode Diolaze device is indicated for use for hair removal and for permanent reduction in hair regrowth, 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) | |
|---|---|
| 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 DIOLAZE DEVICE
510(k) Number K_______________________________________________________________________________________________________________________________________________________________
Applicant Name:
| Company Name: | InMode MD Ltd. |
|---|---|
| Address: | Tabor Building, Shaar Yokneam |
| Yokneam 2069200 | |
| Israel | |
| Tel: +972-4-9097470 | |
| Fax: +972-4-9097471 | |
| E-mail: ahava@asteinrac.com |
Contact Person:
| Official Correspondent: | Ahava Stein |
|---|---|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102 |
| Kfar Saba 4442500 | |
| Israel | |
| Tel: +972-9-7670002 | |
| Fax: +972-9-7668534 | |
| E-mail: ahava@asteinrac.com | |
| Date Prepared: | October 07, 2014 |
| Trade Name: | InMode Diolaze Device |
| Classification Name: | CFR Classification section 878.4810; (Product code GEX) |
| Classification: | Class II Medical Device |
Predicate Device:
The InMode Diolaze device is substantially equivalent to the following predicate devices.
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| InMode MD Ltd. | InMode Hair Removal (HR) Device | K123682 |
| Quantel Derma GmbH | Leda EPI 808 | K090762 |
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Device Description:
The InMode Diolaze device is designed to deliver optical energy to the skin via a precooled 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 scanning system embedded into the laser of the InMode Diolaze device hand piece allows efficient treatment with less risk of overlap. The hand piece has integrated skin cooling to enhance safety and comfort of the treatment.
The InMode Diolaze device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and user interface including an LCD screen and functional buttons. 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 Diolaze device laser with linear scanning system, cooled sapphire output window (8 x 50mm), 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 4°C. The hand piece contains a trigger button which starts the laser scan and radiation. Fluence (light energy density) is delivered within the limits of 10 to 60J/cm². The hand piece has a cable that is 170cm long and connects the hand piece to the console via a connector.
Intended Use/Indication for Use:
The InMode Diolaze device is indicated for use for hair removal and for permanent reduction in hair regrowth, 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.
Performance Standards:
The InMode Diolaze device is identical to the InMode Hair Removal (HR) device (same device). Therefore, the InMode Diolaze device complies with the voluntary performance standards listed below in which the InMode Hair Removal (HR) device was tested and complies with:
- . IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
- o IEC 60601-1-2. (Third Edition, 2007), Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests
- . IEC 60825-1 - Safety of laser products, Part 1: Equipment classification and requirements; (2001)
5
- IEC 60601-2-22 Medical Electrical Equipment Part 2-22: Particular o requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (1995)
Non-Clinical Performance Data:
The InMode Diolaze device is identical to the InMode Hair Removal (HR) device (same device), as such, for this 510k submission the same performance test documents used for K123682 are provided comparing the InMode Hair Removal (HR) device laser output parameters to those of the Leda EPI 808 predicate device. The results of the bench tests demonstrate that the InMode HR device has the same laser output specifications as the predicate Leda EPI 808 device and along with the fact that the InMode Diolaze device is identical to the InMode Hair Removal device, it can be concluded that the InMode Diolaze device is substantially equivalent to the predicate devices.
Clinical Performance Data:
Not Applicable
Substantial Equivalence:
The indications for use of the InMode Diolaze device are substantially equivalent to the indications for use of the Leda EPI 808 predicate device and are an expansion of the indications for use of the InMode Hair Removal (HR) device with the permanent reduction in hair regrowth indication. The design and components in the InMode Diolaze 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 identical to the design and components found in the InMode Hair Removal (HR) (same device) and similar to the Leda EPI 808 predicate devices. The performance specifications (including wavelength, fluence, pulse width, pulse repetition rate, spot size and cooling) in the InMode Diolaze device are identical to performance specifications in the InMode Hair Removal (HR) and similar to the Leda EPI 808 predicate device. The safety features in the InMode Diolaze device are substantially equivalent to the safety features found in the predicate devices. Consequently, the InMode Diolaze device is substantially equivalent to the InMode Hair Removal (HR) predicate device, cleared in 510(k) K123682, and to the Leda EPI 808 predicate device, cleared in 510(k) K090762, and therefore, may be legally marketed in the USA.
Conclusions:
Based on the performance testing and comparison to predicate devices, the InMode Diolaze device is substantially equivalent to the predicate devices listed above.