← Product Code [OHT](/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT) · K160968 # iPulse SmoothSkin Gold Hair Removal Device (K160968) _Cyden Limited · OHT · Apr 14, 2016 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT/K160968 ## Device Facts - **Applicant:** Cyden Limited - **Product Code:** [OHT](/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT.md) - **Decision Date:** Apr 14, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The iPulse SmoothSkin Gold Hair Removal System is an over the counter device intended for the removal of unwanted hair. ## Device Story Intense pulsed light (IPL) system for over-the-counter hair removal. Device consists of a handset containing a xenon arc flashlamp, capacitor, control electronics, optics, and skin tone/proximity sensors (STS). User operates device via finger switch to deliver light pulses (510-1100nm) directly to skin. STS provides continuous optical measurement of skin tone to manage energy delivery (3-6J/cm²). Powered by external 24V DC supply. Intended for home use to achieve permanent hair reduction. Benefits include long-term stable reduction in hair regrowth. ## Clinical Evidence Clinical trial (n=31) evaluated safety on facial regions below the cheekline. Subjects received 12 weekly treatments (330 total). Reported 5 device-related events (1.52% incident rate), including minor spots, erythema, and pruritus. All events resolved within 1-2 weeks. Bench testing confirmed compliance with IEC 60601-1, IEC 60601-1-2, IEC 62471, and ISO 10993 (cytotoxicity, irritation, sensitization). ## Technological Characteristics IPL system using Xenon Arc Flashlamp. Wavelength: 510-1100nm; Pulse duration: 2-10ms; Energy density: 3-6J/cm²; Spot size: 3cm². Features integrated optical skin tone/proximity sensors. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; Photobiological safety per IEC 62471. Biocompatibility per ISO 10993. Powered by external 24V DC supply. ## Regulatory 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. ## Predicate Devices - iPulse SmoothSkin Gold Hair Removal System ([K143003](/device/K143003.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three overlapping shapes. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 14, 2016 Cyden Limited Dr. Mike Kiernan Chief Scientific Officer Technium 2. Kings Road Swansea, SA1 8PJ GB Wales Re: K160968 Trade/Device Name: Ipulse Smoothskin Gold Hair Removal Device 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: OHT, GEX Dated: April 4, 2016 Received: April 6, 2016 Dear Dr. Mike Kiernan: 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 yours, # Jennifer R. Stevenson -A 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}------------------------------------------------ #### 2.0 INDICATIONS FOR USE STATEMENT | 510(k) Number (if known): | Not Known | K160968 | |---------------------------|--------------------------------------------|---------| | Device Name: | iPulse SmoothSkin Gold Hair Removal System | | Indications for Use: The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse Smoothskin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 {3}------------------------------------------------ ### 510(K) SUMMARY 3.0 | Submission Date: | 4th April 2016 | |-----------------------|-------------------------------------------------------------------------------------| | Submitter Information | | | Company Name: | CyDen Limited. | | Company Address: | Technium 2, Kings Road, Swansea, Wales, UK SA1 8PJ | | Contact Person: | Dr Mike Kiernan
UK +44 1792 485 519
mkiernan@cyden.com | | Device Information | | | Trade Name: | iPulse SmoothSkin Gold Hair Removal System | | Common Name: | Light based over the counter hair removal system | | Classification Name: | Laser surgical instrument for use in general and plastic
surgery and dermatology | | Device Class: | 21 CFR 878.4810 | | Predicate Device: | iPulse SmoothSkin Gold Hair Removal System
K143003
CyDen Limited | A comparison of the key technological characteristics of the iPulse SmoothSkin Gold System to the predicate device is provided in the following table. {4}------------------------------------------------ | | PREDICATE DEVICE | DEVICE | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | iPulse SmoothSkin Gold | iPulse SmoothSkin Gold | | K Number | K143003 | | | Manufacturer | CyDen Ltd | CyDen Ltd | | Energy Medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | | Wavelength
Range | 510-1100nm | 510-1100nm | | Pulse Duration | 2ms to 10ms | 2ms to 10ms | | Energy Density | 3-6J/cm² | 3-6J/cm² | | Spot Size | 3cm² (3cm by 1cm) | 3cm² (3cm by 1cm) | | Delivery Device | Direct Illumination to Tissue | Direct Illumination to Tissue | | Pulsing Control | Finger switch | Finger switch | | Skin Tone Sensor | Optical Measurement
Integral to device.
Continuous measurement. | Optical Measurement
Integral to device.
Continuous measurement. | | Specific
Indications for
Use | The iPulse SmoothSkin Gold Hair
Removal System is indicated for the
removal of unwanted hair. The iPulse
SmoothSkin Gold is also indicated for
the permanent reduction in hair
regrowth, defined as the long-term,
stable reduction in the number of
hairs regrowing when measured at 6,
9 and 12 months after the completion
of a treatment regime. | The iPulse SmoothSkin Gold Hair
Removal System is indicated for the
removal of unwanted hair. The iPulse
SmoothSkin Gold is also indicated for
the permanent reduction in hair
regrowth, defined as the long-term,
stable reduction in the number of
hairs regrowing when measured at 6,
9 and 12 months after the
completion of a treatment regime. | Device Description: The iPulse SmoothSkin Gold Hair Removal System is an intense pulsed light (IPL) system consisting of: Handset – contained within the handset is the Capacitor, Capacitor Charger, Control electronics, Optics (Lamp, Filter, Reflector, Light Pipe), Trigger mechanism and Skin Tone / proximity Sensors (STS); External Power Supply – used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a lower DC value, typically 24V. This power supply unit is an "off-the-shelf" component which meets all the relevant electrical safety standards. ## Intended Use The iPulse SmoothSkin Gold Hair Removal System is an over the counter device intended for the removal of unwanted hair. {5}------------------------------------------------ # Indications for Use The iPulse SmoothSkin Gold Hair Removal System is indicated for the removal of unwanted hair. The iPulse SmoothSkin Gold is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime. # Performance Data - Non Clinical Nonclinical and clinical testing has been completed on the iPulse SmoothSkin Hair Removal System. Nonclinical testing included biocompatibility electrical safety testing was performed to, and passed, the following standards: - Electrical Safety - IEC 60601-1:2005+AMD1:2012 (3rd Edition) - Electromagnetic Compatibility - IEC 60601-1-2:2014 - Photobiological safety of lamps and lamp systems - IEC 62471:2006 - Biocompatibility - o ISO 10993-05, "Biological Evaluation of Medical Devices Part 5:2009: Tests for In Vitro Cytotoxicity" - ISO 10993-12, "Biological Evaluation of Medical Devices Part o 12:2012(E): Sample Preparation and Reference Materials" - ISO 10993: Part 10:2010(E), "Tests for irritation and skin sensitization" In addition, the software was validated to meet the principle of the FDA guidance document 'General Principles of Software Validation' and the necessary documentation provided. # Performance Testing - Clinical A clinical trial was performed to assess the safety profile of the SmoothSkin Gold Hair Removal System when used on facial regions below the cheekline. A total of 31 subjects were enrolled, each treated 12 times on a weekly basis. Adverse events were recorded throughout the treatment period and at 1 week post and 3 months post last treatment. A total of 330 treatments were performed and a total of 5 "Device Related Events" (DRE) were recorded – equating to an adverse incident rate of 1.52%. All adverse events were minor in nature and resolved completely within 1-2 weeks. The adverse events reported were as listed in the table below. {6}------------------------------------------------ | Subject ID. | DRE Occurrence | DRE Description | Resolution | |-------------|---------------------|-------------------------------------------------------------------------------------------|------------------------------------| | 10 | Post 8th Treatment | Spots appearing at treatment site (pre-auricular) | Completely resolved within 1 week. | | 11 | Post 5th Treatment | Erythema at treatment site (pre-auricular) | Resolved within 2-3 days | | 14 | Post 3rd Treatment | Pruritus at treatment site (upper-lip) | Resolved within 1 week | | 25 | Post 10th Treatment | Spot at treatment site (pre-auricular) | Resolved within 2 weeks | | 31 | Post 1st Treatment | Delayed erythema appearing at treatment site (pre-auricular) several days after treatment | Resolved within 2-3 days. | # Substantial Equivalence: The iPulse SmoothSkin Gold Hair Removal System has the same intended use, mode of action and similar operational characteristics as the predicate device. Performance data supports that the device is as safe and effective as the predicate devices for its intended use. Therefore, the iPulse SmoothSkin Gold Hair Removal System may be found substantially equivalent to its predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT/K160968](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OHT/K160968) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com