(241 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML components or methodologies. The device uses skin tone sensors to determine output settings, which is a rule-based system, not AI/ML.
No.
The device is indicated for hair removal and permanent reduction in hair regrowth, which are cosmetic procedures, not medical treatments for a disease, injury, or other medical condition.
No.
The device is indicated for hair removal and permanent reduction in hair regrowth, which are treatment functions, not diagnostic.
No
The device description clearly outlines hardware components including a handset with optics, sensors, and control electronics, and an external power supply. This is not a software-only device.
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 is an Intense Pulsed Light (IPL) system used for hair removal and permanent hair reduction. It works by applying light energy to the skin to target hair follicles.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples taken from the body. It directly interacts with the skin and hair follicles.
- Intended Use: The intended use is for hair removal and reduction, not for diagnosing any medical condition or analyzing biological markers.
Therefore, the iPulse SmoothSkin Gold Hair Removal System falls under the category of a therapeutic or aesthetic device, not 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
OHT, ONX, GEX
Device Description
The iPulse SmoothSkin 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
Not Found
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
Clinical testing was conducted in 50 subjects at a single treatment center. Each subject received 12 weekly treatments to the selected body location. Prior to treatment the site was shaved and any hair trimmings removed. The treatment was performed by a suitable operator to ensure consistency of coverage thus enabling accurate efficacy determination. The device output setting for each subject was determined by the measured skin tone at the actual treatment site.
Hair counts were performed on a fixed area located at the center of the treatment site using templates and skin landmarks. All treatment sites were photographed prior to each treatment and at the review point. All subjects were shaved one week prior to both baseline and the 6 and 12 month review points thus ensuring hair count consistency.
Hair counts in the selected area on each subject were determined by 2 independent assessors and the results averaged. The percentage difference in hair count pre and post treatment was calculated and a Paired Sample t-test used to compare means. Only cases where the pre and post treatment hair count areas could be clearly identified on the clinical photographs were analysed.
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.
Usability testing was completed in 24 subjects to evaluate device human factors and label comprehension.
Clinical testing was conducted in 50 subjects at a single treatment center. Each subject received 12 weekly treatments to the selected body location.
Key Results:
Number of Subjects at 6 Months Post Treatment: 50
Hair Reduction at 6 Months Post Treatment: 43.9%
Number of Subjects at 12 Months Post Treatment: 33
Hair Reduction at 12 Months Post Treatment: 36.0%
% of Subjects met success (>30% hair reduction) on all body areas at 12 months post-treatment. Subject Success is defined as greater than 30% hair reduction at all treatment sites at 12 months: 66.7%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Hair Reduction at 6 Months Post Treatment: 43.9%
Hair Reduction at 12 Months Post Treatment: 36.0%
% of Subjects met success (>30% hair reduction) on all body areas at 12 months post-treatment: 66.7%
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2015
iPulse Limited Dr. Michael Kiernan Chief Scientific Officer Technium 2, Kings Road, The Docks Swansea, Wales SA1 8PJ, Wales, United Kingdom
Re: K143003 Trade Name: iPulse SmoothSkin Gold 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, ONX, GEX Dated: May 15, 2015 Received: May 18, 2015
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jennifer R. Stevenson -S
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
Indications for Use
510(k) Number (if known) K143003
Device Name
iPulse SmoothSkin Gold Hair Removal System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3.0 510(K) SUMMARY
| Submission Date: | 15th October 2014 | PREDICATE DEVICES | DEVICE | ||||
|---|---|---|---|---|---|---|---|
| Submitter Information | Device Name | iPulse Hair Removal | |||||
| System | Shaser HRS2 IPL | mē | iPulse Smooth Skin | ||||
| Gold | |||||||
| Company Name: | |||||||
| Company Address: | iPulse Limited. | ||||||
| Technium 2, Kings Road, Swansea, Wales, UK SA1 8PJ | K Number | K130315 | K120080 | K131649 | K143003 | ||
| Contact Person: | Dr Mike Kiernan | ||||||
| UK +44 1792 485 519 | |||||||
| mkiernan@cyden.com | Manufacturer | CyDen Ltd | ShaserInc | Syneron Beauty Ltd | iPulse Ltd | ||
| Device Information | Energy Medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | ||
| Trade Name: | iPulse SmoothSkin Gold Hair Removal System | Wavelength | |||||
| Range | 530-1100nm | 650-1100nm* | 550-1200nm | 510-1100nm | |||
| Common Name: | Light based over the counter hair removal system | Pulse Duration | Variable - | ||||
| Single pulse | |||||||
| 25milliseconds. | |||||||
| to | |||||||
| Double Pulse 20ms | |||||||
| on, 60 ms off. | 30 milliseconds | ~5ms | 2ms to 10ms | ||||
| Classification Name: | Laser surgical instrument for use in general and plastic | ||||||
| surgery and dermatology | Energy Density | 7-10J/cm² | 9J/cm² | Up to 9J/cm² | 3-6J/cm² | ||
| Device Class: | 21 CFR 878.4810 | Spot Size | 3cm² (1.3cm by 2.4 | ||||
| cm) | 2cm² (1cm by 2cm) | 3.3cm2 (3.3cm by | |||||
| 1.0cm) | 3cm² | ||||||
| Predicate Devices: | iPulse Smoothskin Hair Removal System | ||||||
| K130315 | |||||||
| CyDen Limited | Delivery Device | Direct Illumination | |||||
| To Tissue | Direct Illumination to | ||||||
| Tissue | Direct Illumination to | ||||||
| Tissue | Direct Illumination to | ||||||
| Tissue | |||||||
| The Shaser HRS2 IPL Hair Removal System | |||||||
| K120080 | |||||||
| ShaserInc | Pulsing Control | Finger switch | Finger switch | Finger Switch | Finger switch | ||
| mē | |||||||
| K131649 | |||||||
| Syneron Beauty Ltd | Skin Tone Sensor | Optical | |||||
| Measurement | |||||||
| Removable from | |||||||
| Base Unit. |
Sensor moveable to
treatment site | Optical
Measurement
Integral to Base Unit
Sensor fixed in base
unit, treatment site
moved to sensor | Electrical Contact | Optical
Measurement
Integral to device.
Continuous
measurement. |
| Specific
Indications for
Use | The iPulse Hair
Removal System is
an Over-the-counter
device intended for
the removal of
unwanted hair. | The Shaser HRS2 is
an Over-the-counter
device intended for
the removal of
unwanted hair. It is
also intended for
permanent reduction
in unwanted hair.
Permanent hair
reduction is defined
as the long-term
stable reduction in
the numbers of hairs
regrowing when
measured at 6,9 and
12 months after the
completion of a
treatment regimen. | The me is an over-
the-counter device
indicated for the
removal of unwanted
hair. Me is also
intended for
permanent in hair
growth following an
initial treatment
regimen with or
without maintenance
when measured at
6,9 and 12 months. | 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. | | | |
| Table 1: Predicate Device Comparison | | | | | | | |
A comparison of the key technological characteristics of the iPulse Smoothskin Gold System to the predicate devices is provided in Table 1.
CONFIDENTIAL
4
5
Device Description
The iPulse SmoothSkin 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.
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, clinical and usability testing has been completed on the iPulse SmoothSkin Hair Removal System. Nonclinical testing included biocompatibility, electrical safety and software testing.
Usability testing was completed in 24 subjects to evaluate device human factors and label comprehension.
Performance Data - Clinical
Clinical testing was conducted in 50 subjects at a single treatment center. Each subject received 12 weekly treatments to the selected body location. Prior to treatment the site was shaved and any hair trimmings removed. The treatment was performed by a suitable operator to ensure consistency of coverage thus enabling accurate efficacy determination. The device output setting for each subject was determined by the measured skin tone at the actual treatment site.
6
Hair counts were performed on a fixed area located at the center of the treatment site using templates and skin landmarks. All treatment sites were photographed prior to each treatment and at the review point. All subjects were shaved one week prior to both baseline and the 6 and 12 month review points thus ensuring hair count consistency.
Hair counts in the selected area on each subject were determined by 2 independent assessors and the results averaged. The percentage difference in hair count pre and post treatment was calculated and a Paired Sample t-test used to compare means. Only cases where the pre and post treatment hair count areas could be clearly identified on the clinical photographs were analysed.
The efficacy results are provided in Table 2.
| SmoothSkin Gold | |
|---|---|
| Number of Subjects at 6 Months | |
| Post Treatment | 50 |
| Hair Reduction at 6 Months Post | |
| Treatment | 43.9% |
| Number of Subjects at 12 Months | |
| Post Treatment | 33 |
| Hair Reduction at 12 Months Post | |
| Treatment | 36.0% |
| % of Subjects met success (>30% | |
| hair reduction) on all body areas at | |
| 12 months post-treatment. Subject | |
| Success is defined as greater than | |
| 30% hair reduction at all treatment | |
| sites at 12 months.* | 66.7% |
| * The SmoothSkin Gold clinical study only used single treatment sites on | |
| individual subjects. | |
| Table 2: Clinical Efficacy Results |
Substantial Equivalence
The iPulse SmoothSkin Gold 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 Smoothskin Gold 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 Gold Hair Removal System may be found substantially equivalent to its predicate devices.