(85 days)
Not Found
No
The document describes a standard IPL hair removal system with no mention of AI or ML in its description, intended use, or performance studies.
No
The device is described as an "over the counter device intended for the removal of unwanted hair," which is a cosmetic purpose, not a therapeutic one. While it achieves "hair reduction," the indications for use do not state any medical or health-related benefits.
No
The device is described as a hair removal system, which is a therapeutic or cosmetic device, not one used for diagnosis of a disease or condition. Its intended use is for the "removal of unwanted hair."
No
The device description explicitly states it 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." This describes physical hardware components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "removal of unwanted hair." This is a cosmetic or therapeutic purpose, not a diagnostic one.
- Device Description: The device is an intense pulsed light (IPL) system that uses a Xenon flashlamp to deliver optical radiation. This mechanism is used for physical treatment (hair removal), not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. The iPulse SmoothSkin Hair Removal System does not perform this function.
N/A
Intended Use / Indications for Use
The iPulse SmoothSkin Hair Removal System is an over the counter device intended for the removal of unwanted hair.
The iPulse SmoothSkin Hair Removal System is indicated for the removal of unwanted hair.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
The iPulse SmoothSkin Hair Removal System 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter
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 on the iPulse SmoothSkin Hair Removal System. Nonclinical testing included biocompatibility, electrical safety and software testing. Clinical testing was conducted in 29 subjects. Each subject underwent three weekly treatments with SmoothSkin, with follow up reviews at four weeks and six months after the last treatment. The majority of study subjects (83.3%) experienced hair reduction, with a mean hair count reduction of 54.7% at six months. Usability testing was completed in 47 subjects to evaluate device human factors and label comprehension.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
K12 2280 P 1/2
Traditional 510(k) Premarket Notification iPulse SmoothSkin Hair Removal System
3.0 510(K) SUMMARY
| Submission Date: | July 27, 2012 |
|---|---|
| Submitter Information | |
| Company Name: | CyDen, Ltd. |
| Company Address: | Technium 2, Kings Road, Swansea, Wales, UK SA1 8PH |
| Contact Person: | William Cotton |
| CyDen | |
| +44 1792 485 584 | |
| wcotton@cyden.com | |
| Device Information | |
| Trade Name: | iPulse SmoothSkin 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: | Shaser IPL Hair Removal System |
| Shaser Inc, K103560 |
Flash 'N Go
Home Skinovations Inc, K082298 |
| Device Description: | The iPulse SmoothSkin Hair Removal System 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 SmoothSkin Hair Removal System is an over the counter
device intended for the removal of unwanted hair. |
| Indications for Use: | The iPulse SmoothSkin Hair Removal System is indicated for the
removal of unwanted hair. |
| Performance Data: | Nonclinical, clinical and usability testing has been completed on the
iPulse SmoothSkin Hair Removal System. Nonclinical testing included
biocompatibility, electrical safety and software testing. Clinical
testing was conducted in 29 subjects. Each subject underwent three
weekly treatments with SmoothSkin, with follow up reviews at four
weeks and six months after the last treatment. The majority of study |
CyDen Ltd.
Page 7
cr
1
12/2 |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Traditional 510(k) Premarket Notification iPulse SmoothSkin Hair Removal System
subjects (83.3%) experienced hair reduction, with a mean hair count reduction of 54.7% at six months. Usability testing was completed in 47 subjects to evaluate device human factors and label comprehension.
The iPulse SmoothSkin Hair Removal System has the same intended Comparison to Predicate Device: use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the iPulse Smoothskin 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 SmoothSkin Hair Removal System may be found substantially equivalent to its predicate devices. A technical comparison to the predicates is provided below.
| PREDICATE DEVICES | DEVICE | ||
|---|---|---|---|
| Device Name | Flash N' Go | Shaser IPL | iPulse SmoothSkin Hair Removal |
| System | |||
| Manufacturer | Home Skinovations Itd | Shaser Inc | CyDen Limited |
| Energy Medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Wavelength Range | 475-1200nm | 650nm - 1100nm | 530 - 1100nm |
| Pulse Duration | 5 milliseconds | 30milliseconds | Setting I: |
| Single pulse 25milliseconds. | |||
| Setting II: | |||
| Double pulse 15ms on, 10 ms off. | |||
| Setting III: | |||
| Double pulse 10 ms on, 40 ms off. | |||
| Energy Density | 5J/cm2 | 9J/cm2 | 7-10J/cm2 |
| Spot Size | 6cm2 (3cm by 2 cm) | 2cm2 (1cm by 2cm) | 3cm2 (1.3cm by 2.4 cm) |
| Delivery Device | Direct Illumination To Tissue | Direct Illumination to | |
| Tissue | Direct Illumination To Tissue | ||
| Pulsing Control | Finger Switch | Finger Switch | Finger switch |
| Skin Tone Sensor | Optical Measurement | ||
| Integral to Handpiece | |||
| Sensor moveable to | |||
| treatment site | Optical Measurement | ||
| Integral to Base Unit | |||
| Sensor fixed in base unit, | |||
| treatment site moved to | |||
| sensor | Optical Measurement | ||
| Removable from Base Unit | |||
| Sensor moveable to treatment site | |||
| Specific Indications | |||
| for Use | The Flash N'Go is an Over- | ||
| the-counter device | |||
| intended for the removal of | |||
| unwanted hair. | The Shaser IPL is an Over- | ||
| the-counter device | |||
| intended for the removal | |||
| of unwanted hair. | The iPulse SmoothSkin Hair Removal | ||
| System is indicated for the removal | |||
| of unwanted hair. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cyden, Limited % Becker and Associates Consulting, Incorporated Mr. Austin Speier Managing Director 2001 Pennsylvania Avenue, Suite 950 Washington, District of Columbia 20006
OCT
23 2012
Re: K122280 Trade/Device Name: iPulse SmoothSkin 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: July 30, 2012 Received: July 31, 2012
Dear Mr. Speier:
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
3
· Page 2 - Mr. Austin Speier
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 forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Daniel Kraine
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K(228° p 1/1
Traditional 510(k) Premarket Notification iPulse SmoothSkin Hair Removal System
CyDen Ltd. Page 6
INDICATIONS FOR USE STATEMENT 2.0
510(k) Number (if known):
Device Name:
iPulse SmoothSkin Hair Removal System
Indications for Use:
The iPulse SmoothSkin Hair Removal System is indicated for the removal of unwanted hair.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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.P. Odenin for mxm
Page 1 of 1
ision Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122280