(105 days)
Not Found
No
The document describes a photomodulation device with preprogrammed protocols and LED technology, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is intended for the treatment of various conditions, including mild to moderate forms of acne, periorbital wrinkles, and temporary relief of minor muscle and joint pain, arthritis, and muscle spasm, which are all therapeutic indications.
No
The provided text explicitly states that "eLyx PRO is intended to emit in the blue and red region of the spectrum for use in dermatology for treatment" and "for the temporary relief of minor muscle & joint pain." The device description further clarifies it as a "professional photomodulation device designed for use in health office" for "treatment protocols." There is no mention of its use for diagnosis, detection, or assessment of diseases or conditions.
No
The device description explicitly states it is composed of a base unit, flexible arm, and a light emitting head containing LEDs, which are hardware components. While it has a software interface accessed via Wi-Fi, it is not solely software.
Based on the provided information, the eLyx PRO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses described are for the treatment of various dermatological conditions (acne, wrinkles) and pain relief. IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a photomodulation device that emits light onto the body. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device interacts directly with the patient's skin and underlying tissues.
Therefore, the eLyx PRO falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- eLyx PRO is intended to emit in the blue and red region of the spectrum for use in dermatology for treatment of mild to moderate forms of acne
- eLyx PRO is intended to emit in the red and near-infrared region of the spectrum for use in dermatology for treatment of periorbital wrinkles
- eLyx PRO is intended to emit in the red and near-infrared region of the spectrum for the temporary relief of minor muscle & joint pain, arthritis and muscle spasm, and relieving stiffness
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Elyx-PRO is a professional photomodulation device designed for use in health office. It offers 6 preprogrammed treatment protocols using Light Emitting Diodes (LED) technology. It is composed of a base unit containing power supply, a flexible arm and a light emitting head containing (162 blue 470 nm, 180 red 645 nm and 126 infrared 850 nm). The user interface is accessed via Wi-Fi from any multimedia support with a browser. Elyx-PRO is provided with a main cable, a router, protective goggles and a user manual.
LED photomodulation principle is to use LEDs of specific wavelengths and to select accurate stimulation parameters (duration, distance, optical power...) to stimulate targeted biological mechanisms and obtain desired clinical effects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face and/or body
Indicated Patient Age Range
Adult man & woman (except pregnant woman)
Intended User / Care Setting
professional use. / health office.
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)
Several safety test has been performed by independent third party according to following international standard:
- Electrical & mechanical safety → IEC 60601-1:2005 "Medical electrical equipment – part 1: general requirements for basic safety & essential performance"
- Electromagnetic compatibility ✈ IEC 60601-1-2:2007 "Medical electrical equipment – part 1-2: general requirements for basic safety & essential performance - collateral standard: Electromagnetic compatibility - requirements & tests"
- Biocompatibility → ISO 10993-1:2009, ISO 10993-5:2009 & ISO 10993-10:2009 "Biological evaluation of Medical devices – part 1: Evaluation and testing within a risk management process – part 5: Tests for in vitro cytotoxicity – part 10: Tests for irritation & skin sensitization"
- Photo biological safety → IEC 60601-2-57:2011 "Medical electrical equipment – part 2-57: general requirements for basic safety & essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring an cosmetic / aesthetic use"
- Usability → IEC 60601-1-6:2010 "Medical electrical equipment – part 1-6: general requirements for basic safety & essential performance – collateral standard: Usability"
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2017
Intelligent Sensory Concept Sa % Rafael Charra Quality Manager Biolux Institute Sarl 1 Place De La Mediterranee Palavas-les-flots, 34250 FR
Re: K162851 Trade/Device Name: Elyx-pro 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: GEX Dated: October 12, 2016 Received: October 19, 2016
Dear Rafael Charra:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
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
| Form Approved: OMB No. 0910-0120 | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|---|
| Expiration Date: January 31, 2017 | Indications for Use | Food and Drug Administration |
| See PRA Statement below. |
| 510(k) Number (if known) | K162851 |
|---|---|
| Device Name | eLyx PRO |
| Indications for Use (Describe) | - eLyx PRO is intended to emit in the blue and red region of the spectrum for use in dermatology for treatment of mild to moderate forms of acne |
- eLyx PRO is intended to emit in the red and near-infrared region of the spectrum for use in dermatology for treatment of periorbital wrinkles
- eLyx PRO is intended to emit in the red and near-infrared region of the spectrum for the temporary relief of minor muscle & joint pain, arthritis and muscle spasm, and relieving stiffness |
| 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
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FORM FDA 3881 (8/14)
Page 1 of 1
3
Image /page/3/Picture/0 description: The image shows the logo for ISC Group. The logo consists of a square grid of dots, with some dots filled in and some not, and the word "GROUP" written below it. To the right of the grid is the text "ISC" in a stylized font, with the words "SWISS ENGINEERED" written below it. The logo is clean and modern, and the colors are muted.
Image /page/3/Picture/1 description: The image shows a logo with several distinct elements. On the left, there is a square grid of dots, with the dots gradually fading from dark to light. To the right of the dots, the letters 'e' and 'YX' are displayed in a stylized font. Below these elements, the word 'PRO' is written in a similar stylized font, completing the logo design.
510(k) Summary of Safety & Effectiveness for eLyx-PRO
This 510(k) summary of safety & effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92 Date of preparation: August 19th, 2016
-
- Submitter
Intelligent Sensory Concept SA 3 rue du TASSON, CH-1304 SENARCLENS (Switzerland) JoëL CHANTERAUD (C.O.O.) / (0041) 78651-4945 / jchanteraud@isc-sa.ch
- Submitter
Correspondant:
Rafael CHARRA (Quality Manager) BIOLUX INSTITUTE SARL 1 place de la Mediterranee, FR-34250 Palavas-les-Flots (France) (0033) 9845-472-09 / rcharra@bioluxgroup.com
-
- Device
Trade name: eLyx PRO Common name: Photomodulation device Device class: II Panel: General & plastic surgery Regulation number: 878.4810 Classification code & name: GEX – Powered Laser Surgical Instrument
- Device
-
- Device description
Elyx-PRO is a professional photomodulation device designed for use in health office. It offers 6 preprogrammed treatment protocols using Light Emitting Diodes (LED) technology. It is composed of a base unit containing power supply, a flexible arm and a light emitting head containing (162 blue 470 nm, 180 red 645 nm and 126 infrared 850 nm). The user interface is accessed via Wi-Fi from any multimedia support with a browser. Elyx-PRO is provided with a main cable, a router, protective goggles and a user manual.
- Device description
LED photomodulation principle is to use LEDs of specific wavelengths and to select accurate stimulation parameters (duration, distance, optical power...) to stimulate targeted biological mechanisms and obtain desired clinical effects.
-
- Intended Use
Elyx PRO is intended to emit energy in the blue & red region of the spectrum for use in dermatology for treatment of mild to moderate forms of acne.
- Intended Use
4
Image /page/4/Picture/0 description: The image shows the logo for ISC Group Swiss Engineered. The logo consists of a square grid of dots on the left, with the word "GROUP" underneath. To the right of the grid is the letters "ISC" in a stylized font, with the words "SWISS ENGINEERED" underneath.
Image /page/4/Picture/1 description: The image shows a logo with several distinct elements. On the left, there is a square grid of dots, with the dots gradually transitioning from light to dark. To the right of the dots, the letters 'e' and 'YX' are displayed in a stylized font. Below these elements, the word 'PRO' is written in a futuristic, outlined typeface.
Elyx PRO is intended to emit energy in the red & near-infrared region of the spectrum for use in dermatology for treatment of periorbital wrinkles.
Elyx PRO is intended to emit energy in the red & near-infrared region of the spectrum for temporary relief of minor muscle & joint pain, arthritis and muscle spasm, and relieving stiffness
ELyx-PRO targeted population is adult man & woman (except pregnant woman), and it is intended to be used on both face & body (contraindication on broken or damaged skin nor mucosal). The device is indicate to be used between 1 and 10 cm, per session of 2 to 15 minutes twice or thrice a week (depending the protocol).
6. Substantial Equivalence
Elyx PRO has the same intended use (indication for use, targeted population, type & condition of use, anatomical site) as previously cleared predicate devices and work on the same technology: LED light stimulation in the same region of the spectrum, powered with electrical energy. All four devices is designed for professional use.
| Proposed device | Predicates devices | ||||
|---|---|---|---|---|---|
| Device features | eLyx PRO | Omnilux Revive & | |||
| Blue combination | |||||
| K043329 | Omnilux Revive & | ||||
| Plus combination | |||||
| K050216 | Omnilux Plus | ||||
| K043317 | Comments | ||||
| Device class | II | II | II | II | (No change) |
| Intended use | Treatment of | ||||
| periorbital wrinkles; | |||||
| Temporary relief of | |||||
| minor muscle & joint | |||||
| pain, arthritis and | |||||
| muscle spasm, and | |||||
| relieving stiffness; | |||||
| Treatment of mild to | |||||
| moderate forms of | |||||
| acne | Treat dermatological | ||||
| conditions, | |||||
| specifically indicated | |||||
| to treat mild to | |||||
| moderate acne | |||||
| vulgaris | Treatment of | ||||
| periorbital wrinkles | Temporary relief of | ||||
| minor muscle & joint | |||||
| pain, arthritis and | |||||
| muscle spasm; | |||||
| relieving stiffness; | |||||
| promoting the | |||||
| relaxation of muscle | |||||
| tissue and to | |||||
| temporarily increase | |||||
| local blood | |||||
| circulation | The intended use of | ||||
| the eLyx PRO is a | |||||
| combination of the | |||||
| intended use of its | |||||
| predicates. | |||||
| Omnilux Plus also | |||||
| pretend to "promote | |||||
| the relaxation of | |||||
| muscle tissue and to | |||||
| temporarily increase | |||||
| local blood | |||||
| circulation", which is | |||||
| not eLyx PRO claim | |||||
| (No impact to device | |||||
| safety & | |||||
| effectiveness) | |||||
| Size | Base unit: | ||||
| 10.9x6.65x3.66" | |||||
| Head: | |||||
| 10.9x6.65x2.87" | |||||
| 5.80 kg | Base unit: | ||||
| 14.6x7.1x19.3" | |||||
| Head R: 12.6x11.0" | |||||
| Head B: 12.4x13.8" | |||||
| 12 kg | Base unit: | ||||
| 14.6x7.1x19.3" | |||||
| Head R: 12.6x11.0" | |||||
| Head P: 12.4x13.8" | |||||
| 12 kg | Base unit: | ||||
| 14.6x7.1x19.3" | |||||
| Head: 12.4x13.8" | |||||
| 12 kg | Predicates are larger | ||||
| than eLyx PRO but all | |||||
| of them are | |||||
| designed for | |||||
| professional use | |||||
| (No impact to device | |||||
| safety & | |||||
| effectiveness) | |||||
| LED area / LED unit | 183x90mm=165cm2 | ||||
| (Twin mode allows | |||||
| to double the area) | |||||
| Blue: 470 nm (162 | |||||
| units - 0.98 LED/cm2) | |||||
| Red: 633 nm (180 | |||||
| units - 1.1 LED/cm2) | |||||
| NIR: 833 nm (126 | |||||
| units - 0.76 LED/cm2) | 150x280mm=420cm2 | ||||
| Red: 633 nm (1620 | |||||
| units - 3.86 LED/cm2) | |||||
| 150x350mm=525cm2 | |||||
| Blue: 415 nm (480 | |||||
| units - 0.91 LED/cm2) | 150x280mm=420cm2 | ||||
| Red: 633 nm (1620 | |||||
| units - 3.86 LED/cm2) | |||||
| 150x350mm=525cm2 | |||||
| NIR: 830 nm (480 | |||||
| units - 0.91 LED/cm2) | 150x350mm=525cm2 | ||||
| NIR: 830 nm (480 | |||||
| units - 0.91 LED/cm2) | Predicates' LED area | ||||
| are larger than eLyx | |||||
| PRO so they can | |||||
| treat a larger area in | |||||
| one session. In term | |||||
| of Led density (LED | |||||
| per cm2), each | |||||
| device is equivalent | |||||
| (No impact to device | |||||
| safety & | |||||
| effectiveness) | |||||
| Irradiance (mW/cm2) | Blue: up to 88 | ||||
| Red: up to 102 | |||||
| NIR: up to 75.5 | Blue: 40 | ||||
| Red: 105 | Red: 105 | ||||
| NIR: 55 | NIR: 55 | Predicates' | |||
| irradiance are in the | |||||
| range of eLyx PRO | |||||
| irradiance | |||||
| (No change) | |||||
| Use environment | Health office | Health office | Health office | Health office | (No change) |
| Target population | Adult man & woman | ||||
| (expect pregnant) | Adult man & woman | ||||
| (expect pregnant) | Adult man & woman | ||||
| (expect pregnant) | Adult man & woman | ||||
| (expect pregnant) | (No change) | ||||
| Anatomical site | Face and/or body | Face | Face | Face and/or body | (No change) |
| Device features | Proposed device | Predicates devices | Comments | ||
| Work instructions | 5 or 10 cm from the | ||||
| skin surface | |||||
| (depending the | |||||
| protocol) | |||||
| 2 to 15 minutes per | |||||
| session (depending | |||||
| the protocol) | |||||
| 1x to 3x per week | |||||
| during 4 to 12 weeks | |||||
| (depending the | |||||
| protocol) | 1-4 cm from the skin | ||||
| surface | |||||
| 2x 20 minutes per | |||||
| session, | |||||
| 2x per week during 4 | |||||
| weeks | 1-4 cm from the skin | ||||
| surface | |||||
| 20 minutes per | |||||
| session, twice a | |||||
| week for 2 weeks | |||||
| then once a week for | |||||
| 3 other weeks | 1-4 cm from the skin | ||||
| surface | |||||
| 20 minutes per | |||||
| session | |||||
| 2x per week during 5 | |||||
| weeks | Equivalent (No | ||||
| impact to device | |||||
| safety & | |||||
| effectiveness) | |||||
| Programs | 3 preprogrammed | ||||
| protocols (duration, | |||||
| optical power, | |||||
| automatic phase, | |||||
| etc.): Pain, Acne & | |||||
| Anti-wrinkles | Constant optical | ||||
| power output | Constant optical | ||||
| power output | Constant optical | ||||
| power output | Elyx PRO's | ||||
| treatments are | |||||
| preprogrammed | |||||
| depending results of | |||||
| R&D clinical | |||||
| evaluation; the only | |||||
| random parameter is | |||||
| respect (or not) of | |||||
| the care frequency. | |||||
| On the contrary, | |||||
| Omnilux devices do | |||||
| not circumscribe the | |||||
| treatment time | |||||
| which is controlled | |||||
| by the operator; | |||||
| dose of light depend | |||||
| therefore of another | |||||
| random parameter | |||||
| and may result in | |||||
| reduced efficiency | |||||
| (No impact to device | |||||
| safety & | |||||
| effectiveness) | |||||
| Interface | User interface is | ||||
| available on any | |||||
| multimedia device | |||||
| equipped with a | |||||
| browser | |||||
| (Smartphone, tablet, | |||||
| computer...) | LCD display panel + | ||||
| keypad | LCD display panel + | ||||
| keypad | LCD display panel + | ||||
| keypad | eLyx-PRO's interface | ||||
| is deported | |||||
| (No impact to device | |||||
| safety & | |||||
| effectiveness) | |||||
| Power requirements | Input line: 100-240 V | ||||
| (AC) - 50/60Hz - 1.2A | Input line: 90-250 V; | ||||
| 50/60 Hz | Input line: 90-250 V; | ||||
| 50/60 Hz | Input line: 90-250 V; | ||||
| 50/60 Hz | (No change) | ||||
| Material | Plastic enclosure | ||||
| Flexible arm | Plastic enclosure | ||||
| Mechanical arm | Plastic enclosure | ||||
| Mechanical arm | Plastic enclosure | ||||
| Mechanical arm | Elyx PRO passed Test | ||||
| of cytotoxicity (ISO | |||||
| 10993-5), delayed- | |||||
| type hypersensitivity | |||||
| and irritation (ISO | |||||
| 10993-10) | |||||
| (No impact to device | |||||
| safety & | |||||
| effectiveness) | |||||
| FDA-recognized | |||||
| consensus standards | Electrical & | ||||
| mechanical safety: | |||||
| IEC 60601-1:2005 | |||||
| EMC: IEC 60601-1- | |||||
| 2:2007 | |||||
| Biocompatibility: ISO | |||||
| 10993-1:2009 | |||||
| Photo biological | |||||
| safety: IEC 60601-2- | |||||
| 57:2011 | |||||
| Software: IEC | |||||
| 62304:2006 | Electrical & | ||||
| mechanical safety: | |||||
| EN 60601-1:2006 | |||||
| EMC: EN 60601-1- | |||||
| 2:2002 | |||||
| Photo biological | |||||
| safety: IEC 60825- | |||||
| 1:2001 | |||||
| Software: IEC | |||||
| 62304:2006 | Electrical & | ||||
| mechanical safety: | |||||
| EN 60601-1:2006 | |||||
| EMC: EN 60601-1- | |||||
| 2:2002 | |||||
| Photo biological | |||||
| safety: IEC 60825- | |||||
| 1:2001 | |||||
| Software: IEC | |||||
| 62304:2006 | Electrical & | ||||
| mechanical safety: | |||||
| EN 60601-1:2006 | |||||
| EMC: EN 60601-1- | |||||
| 2:2002 | |||||
| Photo biological | |||||
| safety: IEC 60825- | |||||
| 1:2001 | |||||
| Software: IEC | |||||
| 62304:2006 | The only difference | ||||
| is about photo | |||||
| biological safety: | |||||
| Omnilux' product | |||||
| comply with a | |||||
| standard concerning | |||||
| the safety of laser | |||||
| product; Elyx PRO | |||||
| complies with a | |||||
| standard concerning | |||||
| non-laser light | |||||
| source equipment, | |||||
| which seems to be | |||||
| eLyx PRO | Omnilux Revive & | ||||
| Blue combination | |||||
| K043329 | Omnilux Revive & | ||||
| Plus combination | |||||
| K050216 | Omnilux Plus | ||||
| K043317 | |||||
| Proposed device | Predicates devices | ||||
| Device features | eLyx PRO | Omnilux Revive & | |||
| Blue combination | |||||
| K043329 | Omnilux Revive & | ||||
| Plus combination | |||||
| K050216 | Omnilux Plus | ||||
| K043317 | Comments | ||||
| Risk analysis: ISO | |||||
| 14971:2009 | more judicious | ||||
| because LED are not | |||||
| laser | |||||
| (No impact to device | |||||
| safety & | |||||
| effectiveness) |
5
Image /page/5/Picture/0 description: The image shows a logo with two distinct parts. On the left, there is a square grid of dots, with the dots varying in size and color. To the right of the grid, there is a stylized text logo that appears to read "ISC", with the letters intertwined and using a combination of black and light blue colors.
Image /page/5/Picture/1 description: The image shows the word "GROUP" in a simple, sans-serif font. The letters are evenly spaced and appear to be a neutral gray color. The text is horizontally aligned and centered within the image frame.
SWISS ENGINEERED™
Image /page/5/Picture/3 description: The image shows a logo with several distinct elements. On the left, there is a square grid of dots that transition from light to dark. To the right of the dots is a stylized letter 'e' in a gradient color. Further to the right, there is a line drawing of a shape resembling two intersecting 'Y's. Below these elements, the word 'PRO' is written in a modern, outlined font.
6
Image /page/6/Picture/0 description: The image shows a logo with two distinct parts. On the left, there is a square grid of dots, with the dots gradually increasing in size from the top left to the bottom right. The grid is enclosed by a thin, light blue-green square border. To the right of the grid, there is a stylized text logo that appears to read "ISC", with the "I" having a dot above it, the "S" formed by two curved lines of different colors (black and light blue-green), and the "C" formed by a black curved line.
Image /page/6/Picture/1 description: The image shows a logo with several distinct elements. On the left, there is a grid of dots that gradually increase in size from top left to bottom right. To the right of the dots is a stylized letter 'e' in a light gray color. Further to the right, there is a line drawing of a graph-like structure with intersecting lines. Below these elements, the word 'PRO' is written in a thin, light gray font.
7. Performance data
Several safety test has been performed by independent third party according to following international standard:
- -Electrical & mechanical safety → IEC 60601-1:2005 "Medical electrical equipment – part 1: general requirements for basic safety & essential performance"
- -Electromagnetic compatibility ✈ IEC 60601-1-2:2007 "Medical electrical equipment – part 1-2: general requirements for basic safety & essential performance - collateral standard: Electromagnetic compatibility - requirements & tests"
- -Biocompatibility → ISO 10993-1:2009, ISO 10993-5:2009 & ISO 10993-10:2009 "Biological evaluation of Medical devices – part 1: Evaluation and testing within a risk management process – part 5: Tests for in vitro cytotoxicity – part 10: Tests for irritation & skin sensitization"
- -Photo biological safety → IEC 60601-2-57:2011 "Medical electrical equipment – part 2-57: general requirements for basic safety & essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring an cosmetic / aesthetic use"
- -Usability → IEC 60601-1-6:2010 "Medical electrical equipment – part 1-6: general requirements for basic safety & essential performance – collateral standard: Usability"
8. Conclusion
Taking into consideration an analysis of the overall characteristics for the device (safety, indications, intended uses, performance, technology), eLyx-PRO raises no new issues of safety or effectiveness and no significant differences exist compared to its predicate devices. Therefore, eLyx-PRO has been found to be substantially equivalent to previously cleared devices.