(173 days)
No
The device description focuses on the physical components and energy delivery (RF and light), and there is no mention of AI, ML, image processing, or data-driven algorithms for treatment control or analysis.
Yes
The device is described as "intended for non-invasive treatment of mild to moderate periorbital wrinkles," which implies a therapeutic purpose.
No
The device is intended for the non-invasive treatment of wrinkles, not for diagnosing any medical condition.
No
The device description explicitly states it is a handheld device utilizing RF and light energies, including hardware components like an RF generator, LEDs, and an applicator.
Based on the provided information, the Silk'n HST device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the non-invasive treatment of periorbital wrinkles. This is a therapeutic or cosmetic application, not a diagnostic one.
- Device Description: The device utilizes RF and light energies applied directly to the skin. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.), which is the core function of an IVD.
- Performance Studies: The performance studies focus on the reduction of wrinkles and user satisfaction with the treatment, not on the accuracy or reliability of a diagnostic test.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases, monitor health conditions, or screen for specific substances. The Silk'n HST device does not perform any such tests.
N/A
Intended Use / Indications for Use
The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.
Product codes
OHS, PAY
Device Description
The Silk'n HST device is designed as a hand held device, which utilizes both RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n HST device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch that also selects the energy level as manifested using indicators panel. The adaptor connects the applicator to the electrical outlet using its plug and the applicator socket.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital (wrinkles)
Indicated Patient Age Range
adult women
Intended User / Care Setting
over-the-counter home use device
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
Clinical Study:
- Study Type: Clinical study to validate safety and efficacy of RF and optical LED combination.
- Sample Size: 30 eligible adults.
- Data Source: Certified clinic in the US.
- Annotation Protocol: Blinded dermatologists evaluated Fitzpatrick scale score.
- Key Results:
- A statistically significant reduction of 1.49±0.51 Fitzpatrick scores compared with baseline to 3-month follow-up (p
§ 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/1 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 an abstract symbol of three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2017
Home Skinovations Ltd. % Mr. Amit Goren A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba, 44425 Israel
Re: K162784 Trade/Device Name: Silk'n HST 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: OHS, PAY Dated: February 15, 2017 Received: February 21, 2017
Dear Mr. Goren:
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
Jennifer R. Stevenson -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) K162784
Device Name Silk'n HST
Indications for Use (Describe)
The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.
| 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
510(K) SUMMARY SILK'N HST 510(k) Number K162784
| Applicant: | Home Skinovations Ltd.
Tavor Building, POB 533
Yokneam Iillit 2069206 Israel
Tel: +972(4)9097440 Fax: +972(4)9097471
E-mail: amit@asteinrac.com; ahava@asteinrac.com |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amit Goren
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: amit@asteinrac.com; ahava@asteinrac.com |
| Date Prepared: | March 22, 2017 |
| Trade Name: | Silk'n HST |
| Classification Name: | 21 CFR Classification sections 878.4810 and 878.4420; Product
codes OHS and PAY, respectively. |
| Classification: | Class II Medical Device |
Predicate Device
The Silk'n HST device is substantially equivalent to the previously cleared Silk'n FX device, also manufactured by the applicant (Home Skinovations Ltd.). In addition, the Newa"M device is used as a reference predicate.
| Manufacturer | Device | 510(k) No. |
|---|---|---|
| Home Skinovations Ltd. | Silk'n FX | K110301 |
| EndyMed Medical Ltd. | NewaTM | DEN150005 |
Device Description
The Silk'n HST device is designed as a hand held device, which utilizes both RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n HST device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The treatment surface is located at the applicator tip and comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch that also selects the energy level as manifested using indicators panel. The adaptor connects the applicator to the electrical outlet using its plug and the applicator socket.
4
Device Specifications:
| Optical power density: | 55 and 70mW/cm2 (±10%) |
|---|---|
| RF frequency: | 1MHz |
| RF power density: | 10W±20% |
| Input Voltage (nominal): | 90-264 VAC |
| Main Line Frequency (nominal): | 47-63 Hz |
Intended Use/Indication for Use
The Silk'n HST is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV.
Performance Standards
The Silk'n HST device has been tested and complies with the following voluntary recognized standards:
| # | Standard | Description |
|---|---|---|
| 1 | IEC 60601-1:2005 (3rd edition) + | |
| C1:2006 + C2:2007 + Amendment | ||
| 1:2012 or IEC 60601-1: 2012(reprint) | Medical electrical equipment - Part 1: General | |
| requirements for basic safety and essential | ||
| performance | ||
| 2 | IEC 60601-1-2:2007 (3rd & 4th editions) | Medical electrical equipment; |
| Part 1-2: Collateral Standard: Electromagnetic | ||
| compatibility - Requirements and tests | ||
| 3 | IEC 60601-2-2:2009 (5th edition) | Medical electrical equipment; |
| Part 2-2: Particular requirements for the basic safety | ||
| and essential performance of high frequency surgical | ||
| equipment and high frequency surgical accessories | ||
| 4 | IEC 60601-1-6:2010 (3rd edition) + | |
| A1:2013 | Medical electrical equipment Part 1 6 General | |
| requirements for basic safety and essential | ||
| performance Collateral Standard Usability | ||
| 5 | IEC 62366:2007 + A1:2014 | Medical device - Application of Usability |
| engineering to medical devices | ||
| 6 | IEC 60601-1-11:2015 (2nd edition) | Medical electrical equipment - Part 1-11: General |
| requirements for basic safety and essential | ||
| performance - Collateral Standard: Requirements for | ||
| medical electrical equipment and medical electrical | ||
| systems used in the home healthcare environment | ||
| 7 | IEC 60601-2-57:2011 (First edition) for | |
| use in conjunction with | ||
| IEC 60601-1:2005 | Medical electrical equipment - Part 2-57: Particular | |
| requirements for the basic safety and essential | ||
| performance of non-laser light source equipment | ||
| intended for therapeutic, diagnostic, monitoring and | ||
| cosmetic/aesthetic use |
Non-Clinical (Bench) Performance Data
5
The Silk'n HST device was evaluated in a set of performance tests for its conformity with the design requirements specifications and for its optical and RF parameters and temperature profile. The testing included over-heating safety, parameter validation and power accuracy.
Furthermore, the Silk'n HST device underwent software validation testing as well as was tested and found to comply with the Electrical and mechanical safety standard (IEC 60601-1), the electromagnetic compatibility standard (IEC 60601-1-2), the non-laser light source equipment standard (IEC 60601-2-57), the medical electrical equipment standard (IEC 60601-1-11) and the particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2).
The results of the tests demonstrated that all of the device specifications met the system requirements and do not raise new safety or effectiveness concerns.
Animal Performance Data / Histology Data
Not Applicable
Clinical Performance Data
Safety & Effectiveness
In order to validate the safety and efficacy of the RF and optical LED combination, a clinical study was conducted at a certified clinic in the US in 30 eligible adults. The study included 21 treatment sessions every other day, over a period of 6 weeks, and 2 maintenance treatments that were performed 1 and 2 months following treatment sessions ended. The criterion for study success was a statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick scale score according to at least 2 out of 3 blinded dermatologists, as measured 3 months following treatment end compared to baseline. The study results indicate that the combination of RF and optical light energies produces on average a statistically significant reduction of 1.49±0.51 Fitzpatrick scores as compared with baseline to 3-month follow-up (p