(445 days)
No
The summary does not mention AI or ML, and the device description focuses on standard laser technology and a skin tone sensor.
No.
A therapeutic device is typically used to treat a disease, disorder, or injury. This device is for hair removal and reduction, which is a cosmetic purpose, not a medical treatment for a condition.
No.
The device is described as a hair removal device, intended for permanent reduction in hair regrowth using laser energy. Its functions, as detailed in the "Intended Use / Indications for Use" and "Device Description" sections, are therapeutic (hair removal) rather than diagnostic (identifying or characterizing a disease or condition). The skin tone sensor is a safety feature for proper device operation, not for diagnosing a condition.
No
The device description explicitly states it is a "hand-held, hair removal device" that uses "laser energy" and has a "skin tone sensor," indicating it is a physical hardware device. The performance studies also include hardware-related testing like biocompatibility, electrical, EMC, and laser safety.
No, 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").
- Epilaser Absolute Function: The Epilaser Absolute is a device that uses laser energy to directly interact with the hair follicle on the skin surface. It is used on the body, not for testing samples taken from the body.
- Intended Use: The intended use clearly states "hair removal" and "permanent reduction in hair regrowth," which are physical treatments, not diagnostic tests.
- Device Description: The description focuses on the physical mechanism of action (laser energy killing the hair root) and safety features (skin tone sensor), not on analyzing biological samples.
The information provided clearly indicates that the Epilaser Absolute is a therapeutic device for hair removal, not a diagnostic device.
N/A
Intended Use / Indications for Use
Epilaser Absolute 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 Absolute is an over-the-counter, hand-held, hair removal device. It kills the root of the hair follicle using laser energy at 808 or 980nm. The system is designed to be manually targeted onto individual hairs and the laser activates when it is pressed against the skin. A skin tone sensor ensures the user has the correct skin tone prior to laser activation.
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
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
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 IEC . 60601-1-2, IEC 62471, IEC 60825-1, and IEC 60335-2-23.
- Skin tone sensor validation .
- Self-selection and usability human factors testing
Key Metrics
Not Found
Predicate Device(s)
K170790 Epilaser, K141063 LinScan System
Reference Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2022
Epilady 2000 LLC % John Smith Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, District of Columbia 20004-1109
Re: K213105
Trade/Device Name: Epilaser Absolute 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 10, 2022 Received: November 10, 2022
Dear John 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jianting Wang -S
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213105
Device Name Epilaser Absolute
Indications for Use (Describe)
Epilaser Absolute 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)
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K213105 510(k) SUMMARY
Epilady 2000's Epilaser Absolute
Submitter
Epilady 2000 LLC 3 Hacharash St., Industrial Zone Hazor Haglilit, Israel 1035102
Moshe Rosenthal, CEO (p) +972 4 686 0400 (f) +972 4 686 0500 moshe@agrolan.co.il
Date Prepared: November 10, 2022
Device Trade Name: Epilaser Absolute
Common or Usual Name: Powered laser surgical instrument
Classification Name: 21 CFR 878.4810, Class II, GEX , Laser surgical instrument for use in general
and plastic surgery and in dermatology
Predicate Devices
K170790 Epilaser
K141063 LinScan System
Device Description
The Epilaser Absolute is an over-the-counter, hand-held, hair removal device. It kills the root of the hair follicle using laser energy at 808 or 980nm. The system is designed to be manually targeted onto individual hairs and the laser activates when it is pressed against the skin. A skin tone sensor ensures the user has the correct skin tone prior to laser activation.
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Indications for Use
Epilaser Absolute 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.
Summary of Technological Characteristics
Both the Epilaser Absolute and its predicates use light energy for permanent hair reduction. The primary difference between the originally cleared Epilaser and the subject Epilaser Absolute are the addition of a 980 nm model and a modification to the user interface. Use of 980 nm light to permanently remove hair in darker skin types has been cleared in many other laser systems, including the Linscan System (K141063). The Absolute has a spot size, peak power, fluence, and pulse duration within the range or lower than what has been cleared for the predicates. The company has performed laser safety testing per IEC 60601-2-22 and IEC 60825-1 to show continued safety of the modified laser systems.
The user interface differs between original Epilaser and the Absolute. Although the user interface has been modified as compared to the predicate Epilaser (K170790), the interface has been significantly simplified. This is consistent with the activation mechanism used by the TRIA (K120737). The company has performed usability testing to demonstrate continued OTC use.
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 IEC . 60601-1-2, IEC 62471, IEC 60825-1, and IEC 60335-2-23.
- Skin tone sensor validation .
- Self-selection and usability human factors testing ●
Conclusions
The Epilaser Absolute has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor differences in technical characteristics do not raise different questions of safety and effectiveness when used as labeled. Performance data demonstrate that the Epilaser Absolute is substantially equivalent to predicate devices.