ORIGINAL [510(K)] PREMARKET NOTIFICATION * Report K143003 I Pulse Smooth Skin Gold Hair Removal System

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Page 2 – Dr. Michael Kiernan
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, sMisbranding by reference to premarket notifications (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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017

Indications for Use

See PRA Statement below.

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”
FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740

EF

Page 1 of 4
Traditional 510(k) Premarket Notification
iPulse Smoothskin Gold

3.0

iPulse Ltd
Page 14

510(K) SUMMARY

Submission Date:

15th October 2014

Submitter Information
Company Name:
Company Address:

iPulse Limited.
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 Devices:

iPulse Smoothskin Hair Removal System
K130315
CyDen Limited
The Shaser HRS2 IPL Hair Removal System
K120080
ShaserInc
mē
K131649
Syneron Beauty Ltd

A comparison of the key technological characteristics of the iPulse Smoothskin Gold
System to the predicate devices is provided in Table 1.

CONFIDENTIAL

Page 2 of 4
Traditional 510(k) Premarket Notification
iPulse Smoothskin Gold

Device Name

iPulse Ltd
Page 15

PREDICATE DEVICES
Shaser HRS2 IPL

mē

K120080

K131649

DEVICE
iPulse Smooth Skin
Gold
K143003

K Number

iPulse Hair Removal
System
K130315

Manufacturer

CyDen Ltd

ShaserInc

Syneron Beauty Ltd

iPulse Ltd

Energy Medium
Wavelength
Range
Pulse Duration

Xenon Arc Flashlamp
530-1100nm

Xenon Arc Flashlamp
650-1100nm*

Xenon Arc Flashlamp
550-1200nm

Xenon Arc Flashlamp
510-1100nm

Variable Single pulse
25milliseconds.
to
Double Pulse 20ms
on, 60 ms off.
2
7-10J/cm
2
3cm (1.3cm by 2.4
cm)
Direct Illumination
To Tissue
Finger switch
Optical
Measurement
Removable from
Base Unit.

30 milliseconds

~5ms

2ms to 10ms

Up to 9J/cm2
3.3cm2 (3.3cm by
1.0cm)
Direct Illumination to
Tissue
Finger Switch
Electrical Contact

3-6J/cm
2
3cm

Energy Density
Spot Size
Delivery Device
Pulsing Control
Skin Tone Sensor

Specific
Indications for
Use

Sensor moveable to
treatment site
The iPulse Hair
Removal System is
an Over-the-counter
device intended for
the removal of
unwanted hair.

2

9J/cm
2
2cm (1cm by 2cm)
Direct Illumination to
Tissue
Finger switch
Optical
Measurement
Integral to Base Unit
Sensor fixed in base
unit, treatment site
moved to sensor
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.

Direct Illumination to
Tissue
Finger switch
Optical
Measurement
Integral to device.
Continuous
measurement.

The me is an overthe-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.

Table 1: Predicate Device Comparison

CONFIDENTIAL

2

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 longterm, stable
reduction in the
number of hairs
regrowing when
measured at 6, 9 and
12 months after the
completion of a
treatment regime.

Page 3 of 4
Traditional 510(k) Premarket Notification
iPulse Smoothskin Gold

iPulse Ltd
Page 16

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.

CONFIDENTIAL

Page 4 of 4
Traditional 510(k) Premarket Notification
iPulse Smoothskin Gold

iPulse Ltd
Page 17

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.
Number of Subjects at 6 Months
Post Treatment
Hair Reduction at 6 Months Post
Treatment

SmoothSkin Gold
50

Number of Subjects at 12 Months
Post Treatment
Hair Reduction at 12 Months Post
Treatment
% 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.*

43.9%
33
36.0%
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.

CONFIDENTIAL



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