(154 days)
None
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
The device is intended for the "removal of unwanted hair," which is a physiological modification. The clinical study measures "reduction in hair density" as a key metric, further supporting its therapeutic nature.
No
The device is described as an "over the counter device intended for the removal of unwanted hair." Its function is to remove hair, not to diagnose any condition.
No
The device description explicitly states it is composed of a base unit housing electrical and electronic sub-assembly, an umbilical cord, and an applicator with a Xenon flashlamp, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is "removal of unwanted hair." This is a cosmetic or therapeutic purpose, not a diagnostic one.
- Device Description: The description details an intense pulsed light (IPL) system that applies light to the body. This is a physical intervention, not a test performed on biological samples in vitro (outside the body).
- Mechanism of Action: IPL hair removal works by targeting the pigment in hair follicles with light energy, damaging them to inhibit hair growth. This is a direct interaction with the body, not an analysis of a sample.
- Clinical Study: The clinical study measures the reduction in hair density on the body, not the results of a diagnostic test on a sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The iPulse Hair Removal System does not perform this function.
N/A
Intended Use / Indications for Use
The iPulse Hair Removal System is an over-the-counter device intended for the removal of unwanted hair.
Product codes
OHT
Device Description
The iPulse is an intense pulsed light (IPL) system composed of a base unit housing the electrical and electronic sub-assembly and an umbilical cord which is connected to the applicator, located in which is the source of optical radiation, namely a Xenon flashlamp. The system is powered from AC power via an external power converter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg, arm, bikini and underarm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over the counter 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical, clinical and usability testing has been completed for the iPulse Hair Removal System. Nonclinical testing included biocompatibility, electrical safety and software testing. The iPulse Hair Removal System was tested in a clinical study of 61 subjects. Each subject had 12 weekly treatments under clinical supervision. Gel was used with all treatments. Treatment sites included the leg, arm, bikini and underarm. Hair counts were taken in a fixed area located using a template and skin landmarks. The hair count before and after treatment was recorded from photographs and reviewed by independent assessor. The reduction in hair density was calculated. When used as directed, the clinical trial subjects showed on average 31.3% less hair at 6 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The reduction in hair density was calculated. When used as directed, the clinical trial subjects showed on average 31.3% less hair at 6 months.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
14130315
510(K) SUMMARY
| Submission Date: | July 11th 2013 | JUL 1 2 2013 |
|---|---|---|
| Submitter Information | ||
| Company Name: | ||
| Company Address: | CyDen, Ltd. | |
| Technium 2, Kings Road, Swansea, Wales, UK SA1 8PJ | ||
| Contact Person: | Dr Mike Kiernan | |
| CyDen | ||
| +44 1792 485682 | ||
| mkiernan@cyden.com | ||
| Device Information | ||
| Trade Name: | iPulse 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 Devices: | CyDen iPulse Smoothskin M100 series 2: | K122280 |
| Shaser IPL Hair Removal System | ||
| Shaser Inc, | K103560 | |
| Flash 'N Go | ||
| Home Skinovations Inc, | K082298 | |
| Device Description: | The iPulse is an intense pulsed light (IPL) system composed of a | |
| base unit housing the electrical and electronic sub-assembly and an | ||
| umbilical cord which is connected to the applicator, located in which | ||
| is the source of optical radiation, namely a Xenon flashlamp. The | ||
| system is powered from AC power via an external power converter. | ||
| Intended Use: | The iPulse Hair Removal System is an over the counter device | |
| intended for the removal of unwanted hair. | ||
| Indications for Use: | The iPulse Hair Removal System is indicated for the removal of | |
| unwanted hair. | ||
| Performance Data: | Nonclinical, clinical and usability testing has been completed for the | |
| iPulse Hair Removal System. Nonclinical testing included | ||
| biocompatibility, electrical safety and software testing. The iPulse | ||
| Hair Removal System was tested in a clinical study of 61 subjects. | ||
| Each subject had 12 weekly treatments under clinical supervision. | ||
| Gel was used with all treatments. Treatment sites included the leg, | ||
| arm, bikini and underarm. Hair counts were taken in a fixed area | ||
| located using a template and skin landmarks. The hair count before | ||
| and after treatment was recorded from photographs and reviewed by | ||
| independent assessor. The reduction in hair density was |
1
calculated. When used as directed, the clinical trial subjects showed on average 31.3% less hair at 6 months.
Comparison to Predicate Device:
The iPulse Hair Removal System has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the iPulse Hair Removal System and the listed predicate devices do not raise any issues of safety or efficacy. Performance data supports that the device is as safe and as effective as the predicate devices for its intended use. Therefore, the iPulse Hair Removal System may be found substantially equivalent to its predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is oriented towards the upper right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
DEPARTMENT OF HEALTH & HUM AN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20093-0002
July 12, 2013
Cyden Limited % Dr. Michael Kiernan Chief Scientific Officer Technium 2. Kings Road, Swansea. Wales, United Kingdom, SA1 8PJ
Re: K130315
Trade/Device Name: iPulse Hair Removal System 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 Dated: May 30, 2013 Received: June 05, 2013
Dear Dr. 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 10 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 – Dr. Michael Kiernan
forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/deliault:him 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 Small Manufacturers, International and Consumer Assistance 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,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K130315
I.T.
iPulse Hair Removal System
Indications for Use:
Device Name:
The iPulse Hair Removal System is an over-the-counter device intended for removal of unwanted hair.
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)
Neil R Ogden 2013.07.12 07:50:29 -04'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
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