(322 days)
The EpiLight™ Hair Removal System is intended for long term removal of unwanted hair.
The EpiLight TM Hair Removal System is used for the removal of unwanted hair
EpiLight™ Hair Removal System is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its long-term removal
The provided text describes the 510(k) summary for the EpiLight™ Hair Removal System. While it discusses the device's intended use and claims substantial equivalence to predicate devices, it does not provide explicit acceptance criteria in a quantitative format or details of a dedicated study to prove it meets such criteria in the way a modern regulatory submission would.
Instead, the submission relies on a comparison to predicate devices and a general statement about "clearance rates and rate of occurrence of adverse effects."
Here's an analysis of the information provided, fitting it into your requested format as much as possible, with caveats where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit quantitative acceptance criteria are not stated in the document, I will infer what the submission implies regarding performance based on the comparison to predicate devices. The "reported device performance" refers to the general claim of being "as safe and as effective" as the predicates.
| Acceptance Criteria (Inferred from Predicate Equivalence Claim) | Reported Device Performance (EpiLight™ Hair Removal System) |
|---|---|
| Long-term removal of unwanted hair | Effective for long-term removal of unwanted hair |
| Acceptable clearance rates (comparable to predicates) | Clearance rates established and compared to published data on predicate devices; deemed "as effective" as predicates |
| Acceptable rate of adverse effects (comparable to predicates) | Rate of occurrence of adverse effects established and compared to published data on predicate devices; deemed "as safe" as predicates |
| Conformance with IEC601.1-1 for electro-medical devices | Conforms with IEC601.1-1 |
| Compliance with 21 CFR 1040.1 FDA laser performance standard (where applicable, despite not being a laser) | Efforts made to comply with 21 CFR 1040.1 where applicable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A "multi-center clinical study" was conducted, but the specific number of participants (sample size) in this study is not provided in the document.
- Data Provenance: The document states "ESC Medical Systems has also conducted a multi-center clinical study." The origin of the data (country) is not explicitly mentioned, but ESC Medical Systems is based in Yokneam, Israel. It is a prospective clinical study, as it was "conducted" by ESC Medical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study establishes "clearance rates and rate of occurrence of adverse effects," which would typically involve expert assessment, but no details on the number or qualifications of these experts are given.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was one done? No. The study described is a clinical study on the device's effectiveness and safety, not a comparative study of human readers with vs. without AI assistance. The EpiLight™ is a standalone medical device, not an AI-powered diagnostic tool for human readers.
- Effect Size of Human Reader Improvement: Not applicable, as this was not an MRMC study related to AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Was one done? Yes, in principle. The clinical study conducted by ESC Medical Systems on the EpiLight™ Hair Removal System is a standalone performance study. The device is not an algorithm, but a physical electro-optic medical device. The study assessed the device's performance (clearance rates and adverse effects) on its own, without human intervention in the hair removal process itself (though human operators operate the device).
7. Type of Ground Truth Used
The "ground truth" for the clinical study was likely based on:
- Clinical Assessment: Observation of hair clearance (reduction in hair growth/density) over time.
- Adverse Event Reporting: Documentation of any side effects (e.g., skin irritation, burns).
This would typically involve patient follow-ups and physician evaluations. The document states "clearance rates and rate of occurrence of adverse effects... were established," implying a direct clinical observation and measurement of outcomes.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here in the context of machine learning. The EpiLight™ Hair Removal System is an electro-optic device, not an AI/algorithm that requires a training set. The clinical study performed is a performance evaluation of the manufactured device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
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K 963249
1. 510(K) SUMMARY- SUMMARY OF SAFETY AND EFFECTIVENESS
ESC Medical Systems, Ltd Submitter's name:
JUL - 7 1997
Yokneam Industrial Park Submitter's address: PO Box 240 Yokneam 20692 ISRAEL
011-972-4-959-9000 Telephone:
001-972-4-959-9050 Fax:
EpiLight™ Hair Removal System Name of device:
Predicate devices:
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- LT-100 ND: YAG Laser Hair Removal System made by Thermolase Corporation of San Diego, California. 510K #K950019.
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- Epilator 629 made by American Hair Removal System of Southern Pines, North Carolina. 510K #K892514.
Description of device:
EpiLight™ Hair Removal System is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its long-term removal
Summary:
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Pursuant to section 513(I) of the Safe Medical Devices Act of 1990, ESC Medical Systems has elected to include in this premarket notification a Summary of Safety and Effectiveness upon which we believe a substantial equivalence determination for the EpiLight™ Hair Removal System can be based.
It is our understanding that there are presently no FDA regulations describing the form and content of such Summaries. With this in mind, ESC Medical Systems has tried to anticipate what information may be of particular interest to the agency regarding safety and effectiveness of the PhotoDerm® PL.
Intended use:
The EpiLight™ Hair Removal System is intended for long term removal of unwanted hair. The LT-100 ND: Y AG Laser Hair Removal System made by Thermolase Corporation of San Diego, California. 510K #K950019 was classified as a class II medical device by the General and Plastic Surgery Devices Panel. The AHRS Epilator 629 was classified as class III medical device by General and Plastic Surgery Devices Panel. ESC Medical Systems' EpiLight™ Hair Removal System is substantially equivalent to these devices.
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Comparing technical characteristics:
3oth a technical comparison and clinical trials were performed by ESC Medical Systems to establish his equivalence:
ESC has performed a detailed comparison of the technical specifications of predicate device #1 and the EpiLight™ Hair Removal System. The results have documented that the system specifications of EpiLight™ are well within the range of the technical specifications of predicate device #1.
A theoretical study was conducted to establish the temperature distribution resulting from a treatment of a hair follicle by the EpiLight™ Hair Removal System.. The temperatures reached as a result of exposure to the light energy of system, was evaluated. It is the view of ESC Medical Systems that this analysis demonstrates that the EpiLight™ Hair Removal System is an effective way of long term removal of unwanted hair, and is safe in minimizing the adverse effects in the surrounding tissues.
Performance:
In addition, ESC Medical Systems has also conducted a multi-center clinical study in which unwanted hair was treated by the EpiLight™ Hair Removal System. This study was analyzed and the clearance rates and rate of occurrence of adverse effects of the EpiLight™ Hair Removal System were established. This data was compared to published data on the clearance rate and adverse effects of predicate devices. It is ESC's opinion that this comparison demonstrates that the EpiLight™ Hair Removal System is as safe and as effective as the predicate devices in the long term removal of unwanted hair.
No performance standards applicable to the EpiLight™ Hair Removal System have been adopted under Section 514 of the Act. However,
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The EpiLight™ Hair Removal System is an electro medical device and conforms with the voluntary international standard IEC601.1-1, Medical Electrical Equipment, Part 1: General Requirements for Safety.
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Although the EpiLight™ Hair Removal System is not a laser device, substantial equivalence to a laser device is being claimed. As such ESC has made efforts to comply, where applicable, with 21 CFR 1040.1 FDA laser performance standard.
In summary we believe that the analysis, the clinical data and the standards which the EpiLight™ Hair Removal System meets make it substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Zvi Ladin Vice President . . ESC Medical Systems Yokneam Industrial Park PO Box 240 Yokneam 20692, Israel
JUL - 7 1997
Re: K963249
Trade Name: EpiLigh™ Hair Removal System Regulatory Class: II Product Code: GEX Dated: June 9, 1997 Received: June 10, 1997
Dear Dr. Ladin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations. Title 21, I'arts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the
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Page 2 - Dr. Zvi Ladin
Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Alan White
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_ 510(k) Number (if known):__K963249 Device Name:_EpiLighTM Hair_Removal_System Indications For Use: The EpiLight TM Hair Removal System is used for the removal ofunwanted hair
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K963249
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.