(175 days)
Not Found
No
The description focuses on basic sensors (proximity, pigmentation, movement) and standard safety features, with no mention of AI/ML terms or data processing beyond simple sensor input.
No.
The device is intended for hair removal and permanent reduction in hair regrowth, which are aesthetic rather than therapeutic purposes.
No
The device is intended for hair removal and reduction, which is a therapeutic or cosmetic purpose, not a diagnostic one. While it has sensors to ensure safe and proper use (e.g., skin tone and proximity sensors), these are functional and safety features, not diagnostic capabilities to detect or characterize medical conditions.
No
The device description explicitly states it is composed of a hand-held applicator and an external power supply, which are hardware components. It also mentions a lamp, skin proximity sensor, skin pigmentation sensor, and movement sensor, all of which are hardware.
Based on the provided information, the sensiLight™ Plus device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is clearly stated as "removal of unwanted hair" and "permanent reduction in hair regrowth." This is a physical treatment applied to the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a pulsed light hair removal device that works by applying light energy to the skin. This is consistent with a physical treatment device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the sensiLight™ Plus device falls under the category of a therapeutic or aesthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The sensiLight™ Plus device is an over-the-counter device intended for the removal of unwanted hair. The sensiLight™/sensiLight™ Plus is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
Product codes
OHT
Device Description
The sensiLight devices are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight devices is 3 cm².
The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight will not trigger a pulse.
(*) The sensiLight Plus model contains in addition, a movement sensor to prevent pulse overlapping.
Body contact materials were evaluated for biocompatibility with accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2009.
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
Home 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
EL Global Trade Ltd's sensiLight has been successfully tested through bench, usability and safety tests to support the determination of substantial equivalence with predicate devices.
The sensiLight device has been tested and complies with the following voluntary recognized standards:
- IEC 60601-1:2005/EN 60601-1:2006. Medical electric equipment-Part 1 General requirements for Basic safety and essential performance, 300 Ed.
- IEC 60601-1-11:2010. Medical electric equipment-Part 1: Collateral requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-2-57:2011. Medical electrical equipment-Part 2: Particular requirements for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetics/aesthetic use.
- IEC 60601-1-11. Medical electric equipment-Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- FCC part 15, Subpart B. Class B.
- IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
- Software Validation was conducted according to IEC 62304:2006 Medical device software - Software life cycle processes, and; FDA Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices, dated May 11, 2005.
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process and with FDA's Memorandum – #G95 1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (Blue Book Memo G95-1).
- IEC 60601-1-6:2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance and IEC 62366:2007 - Medical devices -Application of usability engineering to medical devices - Collateral standard: Usability and FDA Guidance for Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management (July18,2000) and ISO/IEC 14971:2007 (BS EN ISO 14971:2012) Medical devices – Application of risk management to medical devices.
- IEC 62471:2006, Photo-biological safety of lamps and lamp systems.
Tests results are supporting all labeling claims in order to establish substantial equivalency.
Key Metrics
Not Found
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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, layered on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2014
EL Global Trade Ltd. Dr. Shlomit Segman Quality Assurance and Regulatory Affairs Manager Tzoran 4th Street P.O. Box 8242 Netanya, 42504 - Israel
Re: K140381
Trade/Device Name: sensiLight/sensiLight plus 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: June 15, 2014 Received: July 14, 2014
Dear Dr. Segman:
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
1
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 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/Resourcesfor You/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,
David Krause -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) K140381
Device Name sensiLight/sensiLight Plus
Indications for Use (Describe)
The sensiLight™ Plus device is an over-the-counter device intended for the removal of unwanted hair. The sensiLight™/sensiLight™ Plus is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
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)
Neil R Ogden -S 2014.08.07 11:38:18 -04'00
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3
sensiLight – 510K submission
RD-16044 A0
510(K) SUMMARY FOR EL GLOBAL TRADE LTD.'S SENSILIGHT
DATE PREPARED: FEB 10TH, 2014
1. 510(K) OWNER NAME
EL Global Trade Ltd. Tzoran 4th st, P.O.Box 8242, Netanya 42504, Israel. Phone: +972-9-7889069, Fax: +972-9-7734831.
Contact person name: Dr. Shlomit Segman, QA and RA manager Phone: +972-9-7889069, Fax: +972-9-7734831, E mail: Shlomit@elglobalt.com
2. DEVICE NAME
Common/Usual Name: Light based hair removal deices Proprietary/Trade name: sensiLight (sensiLight and sensiLight Plus) Classification: EL Global Trade Ltd.'s sensiLight device has been classified as Class II device under the following classification names:
| Classification Name | Product
Code | Regulation
Number | Panel |
|-----------------------------------------------|-----------------|----------------------|--------------------------------|
| Light Based Over-The-
Counter Hair Removal | OHT | 878.4810 | General and Plastic
Surgery |
3. PREDICATE DEVICES
EL Global Trade Ltd.'s sensiLight device is substantially equivalent to the following Predicate Device:
- 3.1 Home Skinovations Ltd.'s Glide device, cleared under 510(k) number K131870 at August 14th, 2013.
- 3.2 Home Skinovations Ltd.'s Silk'n Flash N Go,
cleared under 510(k) number K103184 at November 10th, 2010.
DEVICE DESCRIPTION
4
| EL Global Trade Ltd | Tzoran 4th St, P.O.Box 8242, Netanya 42504, Israel
Tel: +972-9-7889069 Fax: +972-9-7734831 |
|------------------------------|-----------------------------------------------------------------------------------------------|
| sensilight - 510K submission | RD-16044-A0 |
sensiLight - 510K submission
The sensiLight devices are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight devices is 3 cm².
The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight will not trigger a pulse.
(*) The sensiLight Plus model contains in addition, a movement sensor to prevent pulse overlapping.
Body contact materials were evaluated for biocompatibility with accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2009.
4. INTENDED USE
The sensiLight is an over the counter devices intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 5.
Table 1 presented in the next pages, compares the similarities and differences of EL Global Trade Ltd.'s sensiLight device to the predicate devices manufactured by Home Skinovations Ltd. as identified above.
5
EL Global Trade Ltd
sensiLight – 510K submission
RD-16036 A0
| Feature | EL Global Trade Ltd.
sensiLight & sensiLight Plus
-New Devices - | Home Skinovations Ltd.
Glide
510(k) no. K131870 | Home Skinovations Ltd.
Silk'n Flash N Go
510(k) no. K103184 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intend of use | The sensiLight is an over the counter device intended for the removal of unwanted hair. The sensiLight is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regime. | The Glide™ device is an over the counter device intended for the removal of unwanted hair. The Glide™ device is also intended for 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 Flash N Go device is an over the counter device intended for the removal of unwanted hair. Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. |
| Operation Principle | Photothermolysis. Light energy is absorbed, heats the hair follicles and interrupts the growth cycle. | Photothermolysis. Light energy is absorbed, heats the hair follicles and interrupts the growth cycle. | Photothermolysis. Light energy is absorbed, heats the hair follicles and interrupts the growth cycle. |
| Technology | Home Pulsed Light | Home Pulsed Light | Home Pulsed Light |
| Comparison of treatment regime | • The 1-4 treatments will be approximately two weeks apart
• Followed by 5-7 treatments plan four-week time intervals.
• Maintenance will be needed from time to time if growth is still visible | • Treatments 1-4 – plan two weeks apart
• Treatment 5-7 – plan four weeks apart
• Treatment 8+ - treat as needed, until desired results are achieved.
Maintenance – from time to time some upkeep may be needed if growth is still visible. | • First 3-4 hair removal sessions will be approximately two weeks apart.
• Sessions 5-7 will be approximately four weeks apart.
• After, use again from time to time if and when needed, until long-term results are achieved. |
| Safety | ○IEC 60601-1:2005/EN 60601-1:2006. Medical electric equipment-Part 1 General requirements for Basic safety and essential performance. | ○IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, | ○IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988 (Second Edition). |
| Feature | EL Global Trade Ltd.
sensiLight & sensiLight
Plus | Home Skinovations
Ltd.
Glide | Home Skinovations
Ltd.
Silk'n Flash N Go |
| | -New Devices - | 510(k) no. K131870 | 510(k) no. K103184 |
| | oIEC 60601-1-11:2010.
Medical electric
equipment-Part 1:
Collateral requirements
for medical electrical
equipment and medical
electrical systems used in
the home healthcare
environment.
oIEC 60601-2-57:2011.
Medical electrical
equipment-Part 2:
Particular requirements
for basic safety and
essential performance of
non-laser light source
equipment intended for
therapeutic, diagnostic,
monitoring and
cosmetics/aesthetic use
oIEC 62471:2006 (First
Edition) Photo-biological
safety of lamps and lamp
systems | 1995.
oEN 6060 1-2-57: 2011
Medical electrical
equipment - Part 2-57:
Particular requirements
for the basic safety and
essential performance of
non-laser light source
equipment intended for
therapeutic, diagnostic,
monitoring and cosmeti
c/aesthetic use.
oEN 62471: 2008
Photobiological safety of
lamps and lamp systems. | |
| EMC | IEC 60601-1-2:2013
(Medical electrical
equipment -fourth Edition).
Part 1-2: General
requirements for basic
safety and essential
performance - Collateral
standard: Electromagnetic
compatibility -
Requirements and tests | IEC 60601-1-2 (2007),
Medical Electrical
Equipment - Part 1-2:
General
Requirements for Safety -
Collateral Standard:
Electromagnetic
Compatibility --
Requirements and Tests | IEC 60601-1-2 (2004),
Medical Electrical
Equipment - Part 1-2:
General
Requirements for Safety -
Collateral Standard:
Electromagnetic
Compatibility --
Requirements and Tests |
| Performance Features | | | |
| Optical
aperture | $3 [cm^2]$ | $2.7 [cm^2]$ | $6 [cm^2]$ |
| Emitted
Spectrum | $475-1200 [nm]$ | $475-1200 [nm]$ | $475-1200 [nm]$ |
| Max energy
level | $5 [joules/cm^2]$ | $5 [joules/cm^2]$ | $5 [joules/cm^2]$ |
| Feature | EL Global Trade Ltd.
sensiLight & sensiLight
Plus | Home Skinovations
Ltd.
Glide | Home Skinovations
Ltd.
Silk'n Flash N Go |
| | -New Devices - | 510(k) no. K131870 | 510(k) no. K103184 |
| (fluence) | | | |
| User
selectable
Energy levels | 3 | 5 | 5 |
| Single pulse
duration | 500-800 [uSec] | 500-800 [uSec] | 500-800 [uSec] |
| Interval
between
pulses | ~2 [Sec] | 1-3.4 [Sec], depending
on energy level | ~ 3.5 [Sec] |
| Power
Supply | External power supply
110-240 VAC, 50-60Hz
to 19VDC, 1.8Amp | External power supply 110-
240 VAC, 2Amp | 110-240 [VAC], 50-60
([Hz]) |
| | Safety Features | | |
| Close contact
detector | Prevent the activation of
the device while not in
close contact with the
skin. | Yes | Yes |
| Pigmentation | Optical - does not allow | Optical - does not allow | Optical - does not allow |
| level detector | activation on dark skin | activation on dark skin | activation on dark skin |
| (*)
Movement
sensor | In the sensiLight Plus
(Second model) | No | No |
| Darkest skin
allowed | Fitzpatrick 4 | Fitzpatrick 4 | Fitzpatrick 4 |
| Materials | oTop, Side and Bottom
shell - ABS/PC plastic
(Acrylonitrile butadiene
styrene/PolyCarbonate)
oOptical Filter - Color
glass which purpose is of
an optical long pass filter
tested for
biocompatibility | oDevice outer body -
ABS/PC plastic
(Acrylonitrile butadiene
styrene/PolyCarbonate)
oOptical Filter - Color
glass which purpose is of
an optical long pass filter
tested for
biocompatibility | oDevice outer body -
ABS/PC plastic
(Acrylonitrile butadiene
styrene/PolyCarbonate)
oOptical Filter - Color
glass which purpose is of
an optical long pass filter
tested for
biocompatibility |
| Overall Design | The sensiLight device is
light based hair removal
system composed of a
hand-held applicator. | The Glide device is light
based hair removal
system composed of a
hand held applicator. | The Flash N Go is light
based hair removal
system composed of a
base unit and hand-held
applicator. |
6
EL Global Trade Ltd
sensiLight – 510K submission
RD-16036 A0
......... EL Global Trade Ltd. 510(k) sensiLight
CONFIDENTIAL
7
EL Global Trade Ltd
sensiLight – 510K submission
RD-16036 A0
8
| EL Global Trade Ltd |
|---|
| --------------------- |
sensiLight - 510K submission
RD-16036 A0
| Feature | EL Global Trade Ltd.
sensiLight & sensiLight
Plus
-New Devices - | Home Skinovations
Ltd.
Glide
510(k) no. K131870 | Home Skinovations
Ltd.
Silk'n Flash N Go
510(k) no. K103184 |
|---------|---------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------|
| Use | Home Use | Home Use | Home Use |
The sensiLight device relies on the same technology: Intense Pulsed Light (IPL) which is the same as both predicate devices. The safety and efficacy of IPL treatment for hair reduction are governed by the following parameters:
- Wavelength of the light emitted: Defines the interaction with specific chromophores (the ● part of the molecule responsible for its color) such as melanin, hemoglobin and water. The sensiLight device and the predicate devices utilize exactly the same wavelength (475 - 1200nm).
- Fluence/flux defines the energy per area (e.g. joules per cm²) for the treatment. The ● sensiLight device and the predicate devices deliver exactly the same maximum energy (5 joules/cm2).
- . Pulse duration - Provides for an efficient heating of the target molecule but not its surroundings. The sensiLight device and the predicate devices utilize exactly the same pulse.
PERFORMANCE DATA 6.
EL Global Trade Ltd's sensiLight has been successfully tested through bench, usability and safety tests to support the determination of substantial equivalence with predicate devices.
The sensiLight device has been tested and complies with the following voluntary recognized standards:
-
- IEC 60601-1:2005/EN 60601-1:2006. Medical electric equipment-Part 1 General requirements for Basic safety and essential performance, 300 Ed.
-
- IEC 60601-1-11:2010. Medical electric equipment-Part 1: Collateral requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
-
- IEC 60601-2-57:2011. Medical electrical equipment-Part 2: Particular requirements for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetics/aesthetic use.
9
sensiLight - 510K submission
RD-16036 A0
-
- IEC 60601-1-11. Medical electric equipment-Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
-
- FCC part 15, Subpart B. Class B.
-
- IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
-
- Software Validation was conducted according to IEC 62304:2006 Medical device software - Software life cycle processes, and; FDA Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices, dated May 11, 2005.
-
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process and with FDA's Memorandum – #G95 1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (Blue Book Memo G95-1).
-
- IEC 60601-1-6:2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance and IEC 62366:2007 - Medical devices -Application of usability engineering to medical devices - Collateral standard: Usability and FDA Guidance for Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management (July18,2000) and ISO/IEC 14971:2007 (BS EN ISO 14971:2012) Medical devices – Application of risk management to medical devices.
-
- IEC 62471:2006, Photo-biological safety of lamps and lamp systems.
Tests results are supporting all labeling claims in order to establish substantial equivalency.
7. SUBSTANTIAL EQUIVALENCE
EL Global Trade Ltd.'s sensiLight is substantial equivalent to the predicate device selected in terms of indication for use, technology, performances, place of use, patient population and nature of body contact.
The Substantial equivalent decision was received based on the following comparison with the predicate device:
The design and components in the sensiLight, including the hand held applicator (with lamp, microcontroller, fan, skin color sensor, skin proximity sensor, indicator LEDs and operational button/s) are similar to the design and components found in the predicate devices (K131870 and K103184). The performance specifications (including light energy
10
sensiLight – 510K submission
RD-16036 A0
power, wavelength and pulse duration) are identical. The safety features found in the devices are the same, including the skin color sensor, skin proximity sensor, etc. These safety features in the sensiLight device are substantially equivalent to the safety features found in the predicate devices. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the new sensiLight device underwent performance testing, including software validation testing and electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2. Usability testing was also successfully conducted.
8. CONCLUSIONS
The evaluation of our device performances demonstrates that it is as safe and as effective as the predicate devices.
..............................................................................................................................................................................