(154 days)
None
No
The summary does not mention AI, ML, or related terms, and the device description focuses on laser technology and visualization.
No.
The device is intended for hair removal and permanent hair reduction, which are considered cosmetic purposes, not therapeutic treatments for a disease, injury, or other medical condition.
No
The device description and intended use clearly state that the Epilaser is a hair removal device, not one used for diagnosis. It uses laser energy to treat hair follicles and includes a viewing screen for targeting, not for identifying medical conditions.
No
The device description explicitly states it is a "hand-held, hair removal device" that uses "focused laser energy" and includes a "hand held laser containing multiple safety features and a dedicated viewing screen." This indicates it is a physical hardware device, not software only. The performance studies also include hardware-specific testing like biocompatibility, electrical, EMC, and laser safety testing.
Based on the provided information, the Epilaser device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal and permanent reduction in hair regrowth. This is a physical treatment applied to the body, not a test performed on biological samples (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Device Description: The device uses focused laser energy to target hair follicles. While it has an integrated microscope and viewing screen for visualization, this is for targeting the treatment area, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. The Epilaser's function is to physically alter hair growth, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
Epilaser is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Product codes
GEX
Device Description
The Epilaser is an over-the-counter, hand-held, hair removal device intended for hair removal on the face below the nose, underarms, and bikini line. It kills the root of the hair follicle using focused laser energy. The system has an integrated microscope and external viewing screen which allows the user to visualize and target individual hairs. The system is composed of a hand held laser containing multiple safety features and a dedicated viewing screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face below the nose, underarms, and bikini line
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
- Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and irritation).
- Software documentation and validation per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
- Electrical, EMC, and laser safety testing per AAMI/EN 60601-1, AAMI/EN EC 60601-1-2, IEC 62471, IEC 60825-1, IEC 60335-2-23, and EN 55014-1.
- Usability testing that showed that all subjects were successful at determining who should use the device and on what anatomic locations the device should be used. In addition, the intended users were successful at performing all critical tasks, with only one user failing in one of the tasks due to abandoning the instructions in the middle of the procedure. This subject was able to perform the task after completely reading the instructions.
- Laser energy deposition at various depths characterization
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2017
Epilady 2000 LLC % John Smith, M.D., J.D. Hogan Lovells US LLP 555 Thirteenth Street. NW Washington, District of Columbia 20004-1109
Re: K170970
Trade/Device Name: Epilaser 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: June 23, 2017 Received: June 23, 2017
Dear Dr. Smith:
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 (DICE) 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 (DICE) 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.
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) K170970
Device Name Epilaser
Indications for Use (Describe)
Epilaser is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K170970 510(k) SUMMARY
Epilady 2000's Epilaser
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Epilady 2000 LLC 3 Hacharash St., Industrial Zone Hazor Haglilit, Israel 1035102
Joseph Miller, Managing Director (p) +972 4 686 0400 (f) +972 4 686 0500 yossie@Epilady.com
Date Prepared: August 29, 2017
Name of Device
Epilaser
Common or Usual Name
Powered laser surgical instrument, GEX
Classification Name
21 CFR 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology, class II
Predicate Devices
TRIA Laser Hair Removal System, TRIA Beauty, Inc. (K090820, K120737)
Device Description
The Epilaser is an over-the-counter, hand-held, hair removal device intended for hair removal on the face below the nose, underarms, and bikini line. It kills the root of the hair follicle using focused laser energy. The system has an integrated microscope and external viewing screen which allows the user to visualize and target individual hairs. The system is composed of a hand held laser containing multiple safety features and a dedicated viewing screen.
Intended Use/Indications for Use
Epilaser is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Epilaser is also intended for permanent reduction in hair
4
regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Summary of Technological Characteristics
The Epilaser is composed of four lasers, a focusing objective, a microscope subassembly, a mechanical key lock, an operation button, an electro-optical sensor, a touch sensor, a battery, an LED, and housing.
The Epilaser is substantially equivalent to the TRIA Laser Hair Removal System, TRIA Beauty Inc. (K090820, K120737). The Epilaser has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Importantly, the two systems have identical laser output parameters. The systems primarily differ in that the Epilaser uses a microscope objective to allow the user to target individual hairs, whereas the predicate system treats a larger area. The minor technological differences between the Epilaser and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Epilaser is substantially equivalent to the TRIA.
Performance Data
The following tests were conducted to establish substantial equivalence:
- . Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and irritation).
- . Software documentation and validation per "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
- . Electrical, EMC, and laser safety testing per AAMI/EN 60601-1, AAMI/EN EC 60601-1-2, IEC 62471, IEC 60825-1, IEC 60335-2-23, and EN 55014-1.
- Usability testing that showed that all subjects were successful at determining who . should use the device and on what anatomic locations the device should be used. In addition, the intended users were successful at performing all critical tasks, with only one user failing in one of the tasks due to abandoning the instructions in the middle of the procedure. This subject was able to perform the task after completely reading the instructions.
- Laser energy deposition at various depths characterization
Conclusions
The Epilaser has the same intended use and identical laser output parameters to the predicate TRIA laser. Safety testing has shown that the Epilaser conforms to applicable electrical, EMC, and laser safety standards. Usability testing demonstrated that users can self-select and use the device. Therefore, the Epilaser is substantially equivalent to the predicate device.