(85 days)
Not Found
No
The description focuses on the hardware components and the mechanism of action (photobiomodulation) without mentioning any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "intended for the use in the treatment of full-face wrinkles," which is a therapeutic purpose.
No
The device description explicitly states: "The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat." This indicates it is not a diagnostic device, as diagnostic devices are used to identify or determine the nature of a disease or condition, which typically involves making measurements or drawing conclusions.
No
The device description clearly outlines multiple hardware components including a silicon mask, controller, power supply, and cables. It is a physical device that emits light for treatment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of full-face wrinkles." This is a therapeutic or cosmetic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and how the device delivers light energy to the skin. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Mechanism of Action: The device works through "Photobiomodulation," a non-thermal mechanism involving light interaction with tissue. This is a physical or biological effect, not a diagnostic process.
- Lack of Diagnostic Elements: There is no mention of measuring biomarkers, analyzing samples, or providing information about a disease state or condition. The device's purpose is to treat, not to diagnose.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The faceLITE LED mask is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
OHS
Device Description
The faceLite consists of;
-
- Silicon flexible face mask
-
- Controller
-
- Power supply and country specific adaptors
-
- USB C to USB A connector
-
- Head straps
faceLite is a home use wearable LED phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment cosmetic indications including facial wrinkles.
The system consists of a flexible silicon mask that contains light emitting diodes (LEDs) and a controller. The LEDs generate the light. The mask is worn on the face and is held in place by an adjustable Velcro strap. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of the same silicone (Methyl vinyl silicone rubber, Genvan GA 3 series GA9 series).
The inner surface contacts with the user's skin. Contact is restricted to normal intact skin and only for a duration of 10 minutes (treatment time). Methyl vinyl silicone rubber GENVAN GA 3 series GA9 series has been tested to those tests specified under ISO 10993-5:2009 tests for in vitro cytotoxicity and ISO10993-10:2010 Tests for irritation and skin sensitization
The controller (Polycarbonate PC1100) switches the LEDs ON/OFF and controls power to the mask. The controller contains a rechargeable Lithium ion polymer battery. The controller uses a visible display comprising of 3 micro LEDs to show the user the battery charge status of the device.
The power supply (SK01T-0500100Z) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The power cable is connected to the controller by a standard micro USB A-C connector. The faceLite cannot be operated while charging.
The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.
The faceLite Light emitting diode (LED) system emits light energy in the red and near infrared (NIR) region of the light spectrum and is intended to treat facial wrinkles through a nonthermal mechanism called Photobiomodulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was conducted according to various IEC and ISO standards for electrical safety, electromagnetic disturbances, usability, home healthcare environment, photobiological safety, battery safety, biological evaluation, and risk management.
Label comprehension testing was performed with 32 subjects (average age 35, 59% female, 18 Caucasian, 14 non-Caucasian, 7 where English was a second language) to demonstrate that the labeling could be used by lay persons to safely and effectively operate the device.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 12, 2019
iSMART Marketing SVCS Ltd Susan D'Arcy Director/Owner 129 Green Lanes, Sutton Coldfield Birmingham, B735LT GB
Re: K191629
Trade/Device Name: faceLITE 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: OHS Dated: June 12, 2019 Received: June 19, 2019
Dear Susan D'Arcy:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or post-marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191629
Device Name faceLITE LED mask
Indications for Use (Describe)
The faceLITE LED mask is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the logo for FaceLITE. The text "faceLITE" is in a sans-serif font, with the "face" portion in a rounded, lowercase style and the "LITE" portion in uppercase. Below the main text, in a smaller font, it reads "FROM THE NATURAL FACELIFT COMPANY".
Section 5: 510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).
Submitter's Name: Ismart Marketing SVCS Ltd.
Submitter's Address: 129 Green Lanes, Sutton Coldfield, Birmingham B735LT
SBDN: SBD195544
Contact Person: Susan D'Arcy iSMART Marketing Services, 129 Green Lanes, Wylde Green, Birmingham B73 5LT. United Kingdom. Telephone +44 (0) 7880313315
Date Prepared: June 12th, 2019
Date Amended: September 9th, 2019
Device Trade Name: faceLITE LED mask
Device Classification Information:
| Regulation
Number | Device Classification
name | Device
Class | Product
Code | Classification
Panel | Type |
|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|-----------------|-----------------|------------------------------|------------------------|
| 21 CFR 878.4810
Laser surgical
instrument for use
in general and
plastic surgery and
in dermatology. | Light Based Over the
Counter Wrinkle
Reduction | Class 2 | OHS | General &
Plastic Surgery | Traditional
510 (k) |
4
Image /page/4/Picture/1 description: The image shows the logo for "faceLITE" in a simple, modern font. The word "face" is in a rounded, sans-serif typeface, while "LITE" is in a more angular, sans-serif font. Below the logo, in smaller letters, is the tagline "FROM THE NATURAL FACELIFT COMPANY."
5.1. Device Description
5.1.1. Overall Description
The faceLite consists of;
-
- Silicon flexible face mask
-
- Controller
-
- Power supply and country specific adaptors
-
- USB C to USB A connector
-
- Head straps
Image /page/4/Figure/10 description: The image shows a white face mask with LED lights on top of a black box. The mask has cutouts for the eyes, nose, and mouth. There is a white controller attached to the mask with three buttons. The image also shows a white power adapter and a black strap. The objects in the image are labeled with numbers 1-5.
faceLite is a home use wearable LED phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment cosmetic indications including facial wrinkles.
The system consists of a flexible silicon mask that contains light emitting diodes (LEDs) and a controller. The LEDs generate the light. The mask is worn on the face and is held in place by an adjustable Velcro strap. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of the same silicone (Methyl vinyl silicone rubber, Genvan GA 3 series GA9 series).
The inner surface contacts with the user's skin. Contact is restricted to normal intact skin and only for a duration of 10 minutes (treatment time). Methyl vinyl silicone rubber GENVAN GA 3 series GA9 series has been tested to those tests specified under ISO 10993-5:2009 tests for in vitro cytotoxicity and ISO10993-10:2010 Tests for irritation and skin sensitization
The controller (Polycarbonate PC1100) switches the LEDs ON/OFF and controls power to the mask. The controller contains a rechargeable Lithium ion polymer battery. The controller
5
K191629
Image /page/5/Picture/1 description: The image shows the logo for FaceLite, a company that specializes in natural facelifts. The logo is in black and white, with the word "faceLITE" in a sans-serif font. Below the company name is the tagline "FROM THE NATURAL FACELIFT COMPANY" in a smaller font. The logo is simple and modern, and it conveys the company's focus on natural beauty.
uses a visible display comprising of 3 micro LEDs to show the user the battery charge status of the device.
The power supply (SK01T-0500100Z) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The power cable is connected to the controller by a standard micro USB A-C connector. The faceLite cannot be operated while charging.
The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent.
The faceLite Light emitting diode (LED) system emits light energy in the red and near infrared (NIR) region of the light spectrum and is intended to treat facial wrinkles through a nonthermal mechanism called Photobiomodulation.
5.2. Intended Use
The faceLITE™ LED mask emits light in the red and near infra-red (NIR) region of the light spectrum and is indicated for the treatment of full face wrinkles.
5.3. Substantial Equivalence
The faceLITE LED mask is substantially equivalent to the LG BEAUTY LED MASK (K170984).
The faceLITE LED Mask is predicated against the LG Beauty LED mask because both masks are LED phototherapy devices intended to emit light in the red and near infra-red region of the light spectrum and indicated for the treatment of full-face wrinkles.
| Property | faceLITE LED
mask | K170984
LG Beauty LED
mask | Significant
differences |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Device Manufacturer | iSMART Marketing
SVCS Ltd | LG Electronics, Inc. | na |
| Device Trade Name | faceLITE™ | LG Beauty™ | na |
| 510(K) Number | - | K170984 | na |
| Device Common
Name | faceLITE™ | LG Beauty™ | na |
| Property | faceLITE LED
mask | K170984
LG Beauty LED
mask | Significant
differences |
| Device Classification
name | Light Based Over the
Counter Wrinkle
Reduction | Light Based Over
the Counter Wrinkle
Reduction | Identical |
| Device Product Code | OHS | OHS | Identical |
| Regulation Number | 878.4810
Laser surgical
instrument for use in
general and plastic
surgery and in
dermatology. | 878.4810
Laser surgical
instrument for use in
general and plastic
surgery and in
dermatology. | Identical |
| FDA Device
Classification | Class II | Class II | Identical |
| Use | Over the Counter | Over the Counter | Identical |
| Intended use and
Indications | The faceLITE LED
mask is an over the
counter device that is
intended for the use
in
the treatment of full-
face wrinkles. | The LG BEAUTY
LED MASK is an
over the counter
device that is
intended for the use
in
the treatment of full-
face wrinkles. | Identical |
| Intended Location of
Use | Face | Face | Identical |
| Energy Type | Light emitting diodes | Light emitting
diodes | Identical |
| Peak Wavelength
(FWHM) | Red: 630nm+/-10nm.
NIR: 830nm+/-10nm | Red: 637nm
NIR:854nm | The output of the
FaceLITE™ LED
mask is within the
predicate's
wavelength |
| Intensity | 30mw/cm² total | 25 mW/cm² total | Similar |
| Treatment time | 600 seconds | 540 seconds | Similar |
| Treatment protocol
(Treatment time) | 5 x weekly, 6 weeks | 5 x weekly, 8 weeks | Similar |
| Property | faceLITE LED
mask | K170984
LG Beauty LED
mask | Significant
differences |
| Cumulative dose | 540J/cm² | 540J/cm² | Identical |
| Timers | Device uses a timer
and software to
control treatment
duration. | Device uses a timer
and software to
control treatment
duration | Identical |
| Software Controlled | Yes | Yes | Identical |
5.3.1 Summary of Substantial Equivalence
6
MPANY FROM THE NATURAL FAC
7
Image /page/7/Picture/1 description: The image shows the logo for "face LITE" in a simple, sans-serif font. The word "face" is written in a rounded, lowercase style, while "LITE" is in uppercase and more angular. Below the main logo, in smaller font, it reads "FROM THE NATURAL FACELIFT COMPANY".
FROM THE NATURAL FACELIFT COMPANY
5.3.2. Substantial Equivalency and Comparison of Technological Similarities & Differences
From the comparative table above, the faceLITE LED Mask demonstrates equivalence to the LG Beauty LED mask. The key similarities are;
- The intended use of the faceLITE LED mask is equivalent to the listed predicate; 1. an over the counter device that is intended for the use in the treatment of full-face wrinkles.
- ii. Both devices are phototherapy units utilizing light emitting diodes that emit in the red and near infra-red-light spectrum.
- iii. Both devices have a similar power density and deliver an identical cumulative dose and have similar treatment protocols.
5.4. Non- clinical performance testing
The faceLITE LED system has been thoroughly evaluated for electrical safety and performance and has been found to conform to the following standards;
IEC/EN 60601-1: 2006 + A12:2014 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
IEC/EN 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
EN 60601-1-6: 2010. AMD12013 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for
8
K191629
Image /page/8/Picture/1 description: The image shows the logo for "faceLITE", a company that specializes in natural facelifts. The logo is in black and white, with the word "faceLITE" in a sans-serif font. Below the company name is the tagline "FROM THE NATURAL FACELIFT COMPANY" in a smaller font. The logo is simple and modern, and it conveys the company's focus on natural beauty.
medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC60601-2-57 1st ed: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 cosmetic/aesthetic use IEC 62471:2006 Photobiological safety of lamps and lamp systems.
IEC62133:2012 2nd ed. Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
ISO 10993-1: 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management.
EN ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
EN ISO 10993-10:2010 ISO 10993-10 Third Edition 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
EN 62304: 2006 (ed. 1.0) Medical Device Software - Software Life Cycle Processes.
ISO 14971: 2012 Medical Devices - Application of Risk Management to Medical Devices
In addition to the aforementioned standards the faceLITE labelling was subject to label comprehension testing. With respect to medical devices available without the intervention of a physician, termed 'Over the Counter' (OTC), the labelling and instructions for use (IFU or User Guide)) must convey to the consumer enough information to allow them to safely operate the device to attain its purpose. To determine the effectiveness of labelling pertaining to a medical device, the labelling and device was tested with an appropriate random sample of users.
A study was conducted and is appended to this section demonstrating comprehension of the faceLITE labelling. 32 subjects took part in the study. The average age of the participants was 35 years of age. Fifty nine percent (59%) of subjects were female (13:19, M:F ratio). In terms of ethnicity 18 subjects classed themselves as Caucasian and 14 non-Caucasian (Black: 4. Hispanic: 6. Indian: 2. Asian: 2). Seven (22%) of subjects indicated that English was their second language. REALM reading tests were conducted.
The comprehension and use test demonstrated that the faceLITE labelling could be used by lay persons to safely and effectively operate the device to attain its intended use and purpose.
9
K191629
Image /page/9/Picture/1 description: The image shows the logo for "faceLITE" in a simple, sans-serif font. The word "face" is in a bolder font than "LITE". Below the logo, in a smaller font, is the text "FROM THE NATURAL FACELIFT COMPANY".
Clinical Performance
Since the faceLITE LED mask raises no new questions in terms of safety and efficacy, clinical data is not required.
Statement of Substantial Equivalence:
513(i) of the FD&C Act (21 U.S.C. 360c(i) states that for substantial equivalence a proposed device is required to have the same intended use and similar technological characteristics as the predicate device. Where there are differences in technological characteristics, these can be negated by appropriate clinical or scientific data demonstrating that the proposed device is as safe and effective as the predicate device, and that the proposed device does not raise any different questions of safety and effectiveness than the predicate device for the same intended use. iSMART Marketing SVCS Ltd has demonstrated that the faceLITE LED mask has an identical intended use, have the same generic classification and basic principles and technologies as the predicate device. Both devices utilize red and NIR wavelengths of light with similar power densities and identical cumulative dose. iSMART Marketing SVCS Ltd has conducted non-clinical performance testing
applicable to those general controls deemed necessary by the agency for this product classification and has determined that the faceLITE LED mask raises no new questions relating to safety and therefore has demonstrated that the faceLITE LED mask is substantially equivalent to the referenced predicate LG Beauty mask (K170984).
June 12th, 2019