(89 days)
No
The description focuses on the hardware components and basic control mechanisms (fluence, pulse duration, scanning system) and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is indicated for hair removal, which is typically considered an aesthetic procedure rather than a therapeutic one aimed at treating a disease or condition.
No
The device description and intended use clearly state that the InMode Hair Removal device is designed for hair removal by delivering optical energy to the skin. There is no mention of it being used to diagnose conditions, analyze medical data, or identify diseases. Its function is purely therapeutic/cosmetic.
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, cooled sapphire output window, and thermoelectric coolers. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The InMode Hair Removal (HR) device delivers optical energy (laser) directly to the skin for the purpose of hair removal. This is a therapeutic or cosmetic procedure performed on the body, not a diagnostic test performed on a sample taken from the body.
- Intended Use: The stated intended use is "for hair removal," which is a treatment, not a diagnostic process.
Therefore, the InMode Hair Removal (HR) device falls under the category of a therapeutic or cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The InMode Hair Removal (HR) device is indicated for use for hair removal.
Product codes
GEX
Device Description
The InMode Hair Removal (HR) device is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between 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 InMode HR 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 Hair Removal 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 HR 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 to 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:
Bench tests were conducted comparing the InMode Hair Removal (HR) device laser output parameters to those of the Leda EPI 808 predicate device. The results of the bench test demonstrate that the InMode HR device has the same laser output specifications as the predicate Leda EPI 808 device and therefore, is substantially equivalent to the predicate device.
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.
0
FEB 27 2013
510(K) SUMMARY
INMODE HAIR REMOVAL (HR) DEVICE
510(k) Number K 123682
Applicant Name:
Company Name: Address:
InMode MD Ltd. Tabor Building, Shaar Yokneam Yokneam 20692 Israel Tel: +972-4-9097470 Fax: +972-4-9097471 E-mail: ahava@asteinrac.com
Contact Person:
Official Correspondent: Ahava Stein
Company Name: Address:
· A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba 44425 Israel Tel: +972-9-7670002 Fax: +972-9-7668534 E-mail: ahava@asteinrac.com
November, 25, 2012 Date Prepared:
InMode Hair Removal (HR) Device Trade Name:
Classification Name: CFR Classification section 878.4810; (Product code GEX)
Classification: Class II Medical Device
Predicate Device:
The InMode Hair Removal (HR) device is substantially equivalent to the following predicate devices.
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Lumenis Ltd., formerly Star | ||
| Medical/Coherent | LightSheer | K001746 |
| Quantel Derma GmbH | Leda EPI 808 | K090762 |
1
Device Description:
The InMode Hair Removal (HR) device is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between 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 InMode HR 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 Hair Removal 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 HR 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 to the hand piece to the console via a connector.
Intended Use/Indication for Use:
The InMode Hair Removal (HR) device is indicated for use for hair removal.
Performance Standards:
The InMode Hair Removal (HR) Device has been tested and complies with the following voluntary recognized standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for ● Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
- IEC 60601-1-2, (Second Edition, 2001), 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;
- IEC 60601-2-22 Medical Electrical Equipment Part 2-22: Particular . requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment;
- IEC 60601-1-4 Medical electrical equipment Part 1-4:General requirements for safety - Collateral Standard: Programmable electrical medical systems
2
Non-Clinical Performance Data:
Additionally, bench tests were conducted comparing the InMode Hair Removal (HR) device laser output parameters to those of the Leda EPI 808 predicate device. The results of the bench test demonstrate that the InMode HR device has the same laser output specifications as the predicate Leda EPI 808 device and therefore, is substantially equivalent to the predicate device.
Clinical Performance Data:
Not Applicable
Substantial Equivalence:
The indications for use of the InMode Hair Removal (HR) device are substantially equivalent to the indications for use of the LightSheer and the Leda EPI 808 predicate devices. The design and components in the InMode Hair Removal (HR) 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 similar to the design and components found in the LightSheer and Leda EPI 808 predicate devices. The performance specifications (including wavelength; fluence, pulse width, pulse repetition rate, spot size and cooling) in InMode Hair Removal (HR) device are similar to performance specifications in the LightSheer and Leda EPI 808 predicate devices. These safety features in the InMode Hair Removal (HR) device are substantially equivalent to the safety features found in the predicate devices. The performance tests demonstrated that any minor differences in the device software and specifications meet the system requirements and do not raise new safety or effectiveness concerns. Consequently, the InMode Hair Removal (HR) device is substantially equivalent to the LightSheer predicate device, cleared under 510(k) K001746, and to the Leda. EPI 808 predicate device, cleared in 510(k) submission K090762, and therefore, may be legally marketed in the USA.
Conclusions:
Based on the performance testing and comparison to predicate devices, the InMode Hair Removal (HR) device is substantially equivalent to the predicate devices listed above.
3
Image /page/3/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three curved lines representing wings or streams.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Inmode Hair Removal (HR) Device % A.Stein-Regulatory Affairs Consulting, Limited Ahava Stein Regulatory Manager 20 Hata'as Street, Suite 102 Kfar Saba, Israel 44425
Re: K123682
Trade/Device Name: InMode Hair Removal (HR) 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, 2012 Received: November 30, 2012
Dear Ahava Stein:
We have reviewed vour 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
February 27, 2013
4
Page 2 - Ahava Stein
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers. International and Consumer Assistance 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,
For
PeterD.Rumm-S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K123682
InMode Hair Removal (HR) Device Name:
Intended Use Statement:
The InMode Hair Removal (HR) device is indicated for use for hair removal.
V Over-The-Counter Use Prescription Use ાર (Per 21 C.F.R. 801 Subpart D) (Optional Format Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2013.02.27 09:32:05 -05'00'
Division of Surgical Devices
510(k) Number K123682