Silk'n Titan Allways

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION". August 30, 2023 Silk'n Beauty Ltd. % Amit Goren Regulatory Manager A. Stein-Regulatory Affairs Consulting Ltd. 18 Hata'as St. Kfar Saba, 444252018 Israel Re: K230013 Trade/Device Name: Silk'n Titan AllWays 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: January 1, 2023 Received: January 3, 2023 Dear Amit 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. 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. {1}------------------------------------------------ 542 of the Act); 21 CFR 1000-1050. 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 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- 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, Digitally signed by Tanisha L. Tanisha L. Hithe -S Hithe -S 08:28:48 -04'00 Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230013 Device Name Silk'n Titan AllWays Indications for Use (Describe) The Silk'n Titan AllWays is an over-the-counter home use device intended for the non-invasive treatment of mild to moderate facial 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 Titan AllWays This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92. # 510(k) Number: K230013 # Applicant Name: | Company Name: | Silk'n Beauty Ltd. | |---------------|--------------------------| | Address: | Alon Ha-Tavor St. 15 | | | Caesarea 3079516, Israel | | | Tel: +972-4-9097470 | | | Fax: +972-4-9097471 | | | amit@asteinrac.com | # Contact Person: | Official Correspondent: | Amit Goren, PhD | | | |-------------------------|-----------------------------------------------------------------------------------------------------------------|------------|---------| | Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. | | | | Address: | 18 Hata'as St.<br>Kfar Saba 4442518 Israel<br>Tel: + 972-9-7670002<br>Fax: +972-9-7668534<br>amit@asteinrac.com | | | | Date Prepared: | August 20, 2023 | | | | Trade Name: | Silk'n Titan AllWays | | | | Classification Name: | OHS 878.4810 Light Based OTC Wrinkle Reduction<br>PAY 878.4420 OTC RF Coagulation Device For Wrinkle Reduction | | | | Classification: | Class II Medical Device | | | | Predicate Device: | The Silk'n Titan Allways is substantially equivalent to the following predicate device: | | | | | Manufacturer | Device | 510(k) | | | Home Skinovations Ltd. | Silk'n HST | K162784 | {4}------------------------------------------------ #### Reason for Submission: In this submission, the Indication for Use has been expanded from treatment of periorbital wrinkles to include treatment of the entire facial area. In addition, several design and safety modifications have been implemented in the Silk'n Titan AllWays. ## Indications for Use: The Silk'n Titan AllWays is an over-the-counter home use device intended for the noninvasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick skin types I-IV. ## Device Description: The Silk'n Titan AllWays is a cordless, hand-held device, utilizing RF energy and low power light spectrum. The device includes an RF generator, an array of 8 LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths respectively), and a temperature stabilizer. The Silk'n Titan AllWays consists of an applicator and an adaptor. The hand-held applicator delivers energy from the treatment surface at the applicator tip which comes in direct contact with the skin. The applicator is equipped with an ON/OFF switch (that also selects the energy level) and an indicators panel. The device can be powered by an internal rechargeable battery (cordless mode) or with the AC adaptor that connects the applicator to an electrical outlet. | Device Characteristics | | Silk'n Titan AllWays<br>(Subject Device) | Silk'n HST Device / K162784<br>(Predicate Device) | |-------------------------|-----------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | Manufacturer | | Silk'n Beauty Ltd. | Home Skinovations Ltd. | | Product Code(s) / Class | | PAY, OHS / Class II | SAME | | Prescription vs. OTC | | OTC | SAME | | Target Population | | Adult women with Fitzpatrick<br>skin types I-IV with mild to<br>moderate facial wrinkles | Adult women with Fitzpatrick<br>skin types I-IV with mild to<br>moderate periorbital wrinkles | | Anatomical Sites | | Entire Face | Periorbital area only | | Environment Used | | Home use device | SAME | | RF<br>Parameters | Max Power | 10W±20% | SAME | | | Frequency | 1 MHz | SAME | ## Comparison of Intended Use and Technological Characteristics: {5}------------------------------------------------ | | Waveform | Sinusoidal | SAME | |-------------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Optical<br>Parameters | Red LEDs | 630±20nm / 45 mW/cm2 | 630±20nm / 70 mW/cm2 | | | IR LEDs | 850±20nm / 57 mW/cm2 | 850±20nm / 55 mW/cm2 | | Energy<br>Source | Li-ion<br>Battery | 3.7VDC / 2600 mAh | N/A | | | AC Adaptor | 100-240V / 50-60Hz / 0.5A<br>12VDC±10% | SAME | | | Surface Area | 4.7 cm2 | SAME | | Applicator<br>Treatment | RF<br>Electrodes | 3 | SAME | | | LEDs | 8 | SAME | | Safety Features | | • Safety proximity sensing<br>• Temperature sensor<br>• Visual user interface with<br>indicator LEDs for device<br>status<br>• Timer to stop RF energy<br>delivery after 15 minutes | SAME | | Standards Met | | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-57<br>IEC 60601-1-11<br>IEC 60601-2-2 | SAME | | Biocompatibility | | Materials in contact with skin are<br>biocompatible | SAME | | Sterility | | Not sterile | SAME | ## Non-Clinical Performance Testing: The Silk'n Titan AllWays device has been tested and complies with the following voluntary recognized standards: - IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance. - IEC 60601-1-2:2014, (Fourth Edition), Medical Electrical Equipment Part 1-2: . General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. - IEC 60601-2-57, (First Edition, 2011), Medical Electrical Equipment Part 2: . Particular Requirements for the Basic Safety and Essential Performance of Non- {6}------------------------------------------------ Laser Light Source Equipment Intended for Therapeutic, Diagnostic, Monitoring and Cosmetic/Aesthetic Use. - IEC 60601-1-11:2015 (Second Edition), Medical electrical equipment Part 1-. 11 – Requirements for the medical electrical equipment and medical electrical systems used in the home healthcare environment. - . IEC 60601-1-6:2010 (Third Edition) + A1:2013, Medical Electrical Equipment -Part 1-6 General requirements for safety - Collateral Standard: Usability. - . The Silk'n Titan AllWays 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 overheating safety, power accuracy, and system parameter validation. - The Silk'n Titan AllWays device underwent software validation testing. electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2, and non-laser light source equipment testing according to IEC 60601-2-57. The results of the tests demonstrated that all the device specifications meet the system requirements and do not raise new safety or effectiveness concerns. #### Animal Performance Data / Histology Data: Not Applicable. ## Clinical Performance Data: - . 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 32 eligible adult women. The study included 2 treatment sessions a week for 10 consecutive weeks, and 2 maintenance treatments that were performed 1- and 3months following treatment end. The study results indicate that the combination of RF and optical light energies produces a statistically significant average reduction of 1.39 Fitzpatrick scores comparing baseline to 3-month follow-up (p < 0.001), as determined by 3 blinded evaluators. In addition, statistical analysis revealed improvement of at least 1 score according to the Fitzpatrick Wrinkle and Elastosis scale for most patients. During the study, no unexpected adverse events were detected, and the treatment was associated with mild to no pain. Usability parameters were also tested indicating that the device is easy and safe to operate. In addition, a separate Usability Study was conducted which demonstrated that device labeling provides adequate comprehension and selfselection for potential users. The study showed as well that the device is easy to operate by potential end users and safe under actual use conditions. Finally, thermal testing was conducted in a human volunteer to show that the worst-case energy and power deposition from the device is not likely to raise skin temperature to above safe, acceptable values. {7}------------------------------------------------ # Conclusion: Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.