(8 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard IPL technology components and sensors.
No
The device is indicated for hair removal and permanent reduction in hair regrowth, which are cosmetic rather than therapeutic indications.
No
The device is indicated for hair removal and permanent reduction in hair regrowth, which are therapeutic functions, not diagnostic.
No
The device description explicitly lists hardware components such as a Handset containing a Capacitor, Capacitor Charger, Control electronics, Optics (Lamp, Filter, Reflector, Light Pipe), Trigger mechanism, and Skin Tone / proximity Sensors, as well as an External Power Supply. While software validation is mentioned, the device is clearly a physical system with integrated hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The iPulse SmoothSkin Gold Hair Removal System uses intense pulsed light (IPL) to remove unwanted hair and reduce hair regrowth. This is a physical treatment applied to the body's surface.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is based on the interaction of light with hair follicles.
Therefore, the device's intended use and mechanism of action clearly place it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OHT, GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial regions below the cheekline
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
adverse incident rate of 1.52%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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.