(105 days)
- 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
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.
The provided text does not contain any information about clinical studies that establish acceptance criteria or demonstrate device performance against such criteria for the eLyx-PRO device.
The document is a 510(k) Summary of Safety & Effectiveness, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting de novo clinical study results that would typically include acceptance criteria and performance metrics.
Specifically, the document states:
- "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."
- Under "6. Substantial Equivalence," it compares features and intended uses to predicates, noting that the eLyx PRO's intended use is a "combination of the intended use of its predicates."
- "7. Performance data" lists various safety tests performed according to international standards (e.g., electrical, EMC, biocompatibility, photobiological safety, usability). These are engineering and safety benchmarks, not clinical performance metrics tied to acceptance criteria for the intended therapeutic effects (acne, wrinkles, pain relief).
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text. The document relies on substantial equivalence and compliance with general safety standards, not on new clinical performance data establishing efficacy against predefined acceptance criteria.
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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
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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
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| 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.
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FORM FDA 3881 (8/14)
Page 1 of 1
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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
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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 combinationK043329 | Omnilux Revive &Plus combinationK050216 | Omnilux PlusK043317 | Comments |
| Device class | II | II | II | II | (No change) |
| Intended use | Treatment ofperiorbital wrinkles;Temporary relief ofminor muscle & jointpain, arthritis andmuscle spasm, andrelieving stiffness;Treatment of mild tomoderate forms ofacne | Treat dermatologicalconditions,specifically indicatedto treat mild tomoderate acnevulgaris | Treatment ofperiorbital wrinkles | Temporary relief ofminor muscle & jointpain, arthritis andmuscle spasm;relieving stiffness;promoting therelaxation of muscletissue and totemporarily increaselocal bloodcirculation | The intended use ofthe eLyx PRO is acombination of theintended use of itspredicates.Omnilux Plus alsopretend to "promotethe relaxation ofmuscle tissue and totemporarily increaselocal bloodcirculation", which isnot eLyx PRO claim(No impact to devicesafety &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 largerthan eLyx PRO but allof them aredesigned forprofessional use(No impact to devicesafety &effectiveness) |
| LED area / LED unit | 183x90mm=165cm2(Twin mode allowsto double the area)Blue: 470 nm (162units - 0.98 LED/cm2)Red: 633 nm (180units - 1.1 LED/cm2)NIR: 833 nm (126units - 0.76 LED/cm2) | 150x280mm=420cm2Red: 633 nm (1620units - 3.86 LED/cm2)150x350mm=525cm2Blue: 415 nm (480units - 0.91 LED/cm2) | 150x280mm=420cm2Red: 633 nm (1620units - 3.86 LED/cm2)150x350mm=525cm2NIR: 830 nm (480units - 0.91 LED/cm2) | 150x350mm=525cm2NIR: 830 nm (480units - 0.91 LED/cm2) | Predicates' LED areaare larger than eLyxPRO so they cantreat a larger area inone session. In termof Led density (LEDper cm2), eachdevice is equivalent(No impact to devicesafety &effectiveness) |
| Irradiance (mW/cm2) | Blue: up to 88Red: up to 102NIR: up to 75.5 | Blue: 40Red: 105 | Red: 105NIR: 55 | NIR: 55 | Predicates'irradiance are in therange of eLyx PROirradiance(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 theskin surface(depending theprotocol)2 to 15 minutes persession (dependingthe protocol)1x to 3x per weekduring 4 to 12 weeks(depending theprotocol) | 1-4 cm from the skinsurface2x 20 minutes persession,2x per week during 4weeks | 1-4 cm from the skinsurface20 minutes persession, twice aweek for 2 weeksthen once a week for3 other weeks | 1-4 cm from the skinsurface20 minutes persession2x per week during 5weeks | Equivalent (Noimpact to devicesafety &effectiveness) |
| Programs | 3 preprogrammedprotocols (duration,optical power,automatic phase,etc.): Pain, Acne &Anti-wrinkles | Constant opticalpower output | Constant opticalpower output | Constant opticalpower output | Elyx PRO'streatments arepreprogrammeddepending results ofR&D clinicalevaluation; the onlyrandom parameter isrespect (or not) ofthe care frequency.On the contrary,Omnilux devices donot circumscribe thetreatment timewhich is controlledby the operator;dose of light dependtherefore of anotherrandom parameterand may result inreduced efficiency(No impact to devicesafety &effectiveness) |
| Interface | User interface isavailable on anymultimedia deviceequipped with abrowser(Smartphone, tablet,computer...) | LCD display panel +keypad | LCD display panel +keypad | LCD display panel +keypad | eLyx-PRO's interfaceis deported(No impact to devicesafety &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 enclosureFlexible arm | Plastic enclosureMechanical arm | Plastic enclosureMechanical arm | Plastic enclosureMechanical arm | Elyx PRO passed Testof cytotoxicity (ISO10993-5), delayed-type hypersensitivityand irritation (ISO10993-10)(No impact to devicesafety &effectiveness) |
| FDA-recognizedconsensus standards | Electrical &mechanical safety:IEC 60601-1:2005EMC: IEC 60601-1-2:2007Biocompatibility: ISO10993-1:2009Photo biologicalsafety: IEC 60601-2-57:2011Software: IEC62304:2006 | Electrical &mechanical safety:EN 60601-1:2006EMC: EN 60601-1-2:2002Photo biologicalsafety: IEC 60825-1:2001Software: IEC62304:2006 | Electrical &mechanical safety:EN 60601-1:2006EMC: EN 60601-1-2:2002Photo biologicalsafety: IEC 60825-1:2001Software: IEC62304:2006 | Electrical &mechanical safety:EN 60601-1:2006EMC: EN 60601-1-2:2002Photo biologicalsafety: IEC 60825-1:2001Software: IEC62304:2006 | The only differenceis about photobiological safety:Omnilux' productcomply with astandard concerningthe safety of laserproduct; Elyx PROcomplies with astandard concerningnon-laser lightsource equipment,which seems to be |
| eLyx PRO | Omnilux Revive &Blue combinationK043329 | Omnilux Revive &Plus combinationK050216 | Omnilux PlusK043317 | ||
| Proposed device | Predicates devices | ||||
| Device features | eLyx PRO | Omnilux Revive &Blue combinationK043329 | Omnilux Revive &Plus combinationK050216 | Omnilux PlusK043317 | Comments |
| Risk analysis: ISO14971:2009 | more judiciousbecause LED are notlaser(No impact to devicesafety &effectiveness) |
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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.
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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.
§ 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.