(142 days)
No
The device description and performance studies focus solely on the physical properties of the LED light and its effect on wrinkles, with no mention of AI or ML algorithms for analysis, control, or personalized treatment.
Yes.
The device is intended for the treatment of full face wrinkles, which constitutes a therapeutic purpose.
No
The device is intended for treatment (reduction of wrinkles) and does not perform any diagnostic function.
No
The device description explicitly mentions hardware components such as the mask containing LEDs, a controller, and a power supply unit.
Based on the provided information, the LG BEAUTY LED MASK is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health by analyzing samples like blood, urine, tissue, etc.
- The LG BEAUTY LED MASK is a therapeutic device. Its intended use is for the treatment of full face wrinkles by applying light directly to the skin. It does not involve the analysis of any biological specimens.
The description clearly indicates it's a device that emits light onto the face for a therapeutic effect, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The LG BEAUTY 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 LG BEAUTY LED MASK is a device which allows emission of LED light in the RED (637 nm) and IR (854 nm) spectrum on to the face, which induces photobiological effect to the face for reduction of wrinkle. The LG BEAUTY LED MASK include the mask that contains LEDs on the inner surface, the controller which turns on and off the device, and the power supply unit that delivers electrical power to the controller for operation or for charging the battery contained in the controller.
Users place the lightweight mask over the face, and use the controller to operate the LG BEAUTY LED MASK. The device will automatically turn off after each treatment. Emitted light from LEDs are not intended for ocular or ophthalmic treatment. To prevent irradiation of LED lights to eyes during the treatment, LG BEAUTY LED MASK has protective eyecup which blocks light energy from LEDs.
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
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 tests: Measurement of wavelength, average output power, and total irradiance (power density, in units of mW/cm2) of treatment LEDs were performed. Other performance, such as optical hazard, electromagnetic compliance, etc, were tested using following consensus standards:
- Basic safety and essential performance of the LG BEAUTY LED MASK is tested and evaluated according to the FDA-recognized consensus standard, IEC 60601-1.
- Effect to the device by electromagnetic disturbances were tested and evaluated using -IEC 60601-1-2.
- Optical hazard was evaluated using IEC 62471-1. -
- -Risk management was recorded by referring to ISO 14971.
- -Usability was documented using IEC 62366-1.
The portion of the device that touches patient body is made of polypropylene, polycarbonate plastic, and silicone, which have been used for other medical devices without any biocompatibility risk.
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.
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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2017
LG Electronics. Inc. % Minusk Kim BT Solutions, Inc. Unit 502, 148 Yuksamro Seoul, Gangnam-gu 06249 Republic of Korea
Re: K170984
Trade/Device Name: LG Beauty LED Mask 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: July 19, 2017 Received: July 21, 2017
Dear Minusk Kim:
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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) 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 (DICE) 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 -
S3
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) K170984
Device Name LG BEAUTY LED MASK
Indications for Use (Describe)
The LG BEAUTY LED MASK is an over the counter device that is intended for the use in the treatment of full face wrinkles.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
6. 510(k) Summary
1. General Information
Date of preparation of 510(k) summary: July 16, 2017
Submitter: LG Electronics, Inc. Address: 222 LG-ro Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17709, Rep. of Korea (South Korea)
Contact Person: Minsuk Kim, BT Solutions Telephone: +82.2.538.9140 Email: cto@btsolutions.co.kr
2. Device Name and Code
| Device Name: | LG BEAUTY LED MASK |
|---|---|
| Trade Name: | LG BEAUTY LED MASK |
| Classification Name: | Light Based Over The Counter Wrinkle Reduction |
| Product Code: | OHS |
| Regulation Number: | 878.4810 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery (ODE) |
| Division of Surgical Devices (DSD) | |
| General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
3. Predicate Devices
LG BEAUTY LED MASK is substantially equivalent to the following devices
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Pulsaderm LLC | Pulsaderm Wrinkle Mask 28 and | |
| Wrinkle Mask 72 | K163329 | |
| Trophy Skin, Inc. | Rejuvalite MD | K133896 |
Table 6.1 Predicate devices
Table 6.2 Reference device
| Applicant | Device Name | 510(k) Number |
|---|---|---|
| Photo Therapeutics, Ltd | illuMask Acne Light Therapy Mask | K123999* |
*This device is considered as reference device, of which only limited aspects are equivalent to those of the LG BEAUTY LED MASK.
4. Device Description
The LG BEAUTY LED MASK is a device which allows emission of LED light in the RED (637 nm) and IR (854 nm) spectrum on to the face, which induces photobiological effect to the face for reduction of wrinkle. The LG BEAUTY LED MASK include the mask that contains LEDs on the inner surface, the controller which turns on and off the device, and the
4
510(k) Summary
power supply unit that delivers electrical power to the controller for operation or for charging the battery contained in the controller.
Users place the lightweight mask over the face, and use the controller to operate the LG BEAUTY LED MASK. The device will automatically turn off after each treatment. Emitted light from LEDs are not intended for ocular or ophthalmic treatment. To prevent irradiation of LED lights to eyes during the treatment, LG BEAUTY LED MASK has protective eyecup which blocks light energy from LEDs.
5. Indications / Intended Use
The LG BEAUTY LED MASK is an over the counter device that is intended for the use in the treatment of full face wrinkles.
6. Technical Characteristics in Comparison to Predicate Devices
| Predicate Device | Predicate Device | Proposed Device | |
|---|---|---|---|
| Applicant | Pulsaderm LLC | Trophy Skin, Inc. | LG Electronics |
| Device Name | Pulsaderm Wrinkle | ||
| Mask 28 and Wrinkle | |||
| Mask 72 | Rejuvalite MD | LG BEAUTY LED | |
| MASK | |||
| 510(k) | |||
| number | K163329 | K133896 | N/A |
| Product Code | OHS | OHS | OHS |
| Intended Use | The Pulsaderm Wrinkle | ||
| Masks 28 and 72 are | |||
| intended for the use in | |||
| the treatment of facial | |||
| wrinkles and for people | |||
| with Fitzpatrick Skin | |||
| Types I, II and III | The Rejuvalite MD is | ||
| an over-the-counter | |||
| device 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. | |||
| LED | |||
| emission | Emission of red (620- | ||
| 630 nm) and IR (850 | |||
| nm) | Emission of red (600, | ||
| 622, 660 nm) and IR | |||
| (820 nm) | RED (637 nm) and IR | ||
| (854 nm) | |||
| LED power | 21.18 - 25.35 mW/cm $^{2}$ total | 62 mW/cm $^{2}$ total | 25 mW/cm $^{2}$ total |
| Treatment | |||
| time | 15 minutes everyday | 3 minutes daily | |
| 5 days per week for 8 | |||
| weeks | 9 minutes daily | ||
| 5 days per week for 8 | |||
| weeks |
LG BEAUTY LED MASK is substantially equivalent to the following devices
7. Performance Data
Non-clinical tests: Measurement of wavelength, average output power, and total irradiance (power density, in units of mW/cm2) of treatment LEDs were performed. Other performance, such as optical hazard, electromagnetic compliance, etc, were tested using following consensus standards:
- Basic safety and essential performance of the LG BEAUTY LED MASK is tested and evaluated according to the FDA-recognized consensus standard, IEC 60601-1.
5
510(k) Summary
- Effect to the device by electromagnetic disturbances were tested and evaluated using -IEC 60601-1-2.
- Optical hazard was evaluated using IEC 62471-1. -
- -Risk management was recorded by referring to ISO 14971.
- -Usability was documented using IEC 62366-1.
The portion of the device that touches patient body is made of polypropylene, polycarbonate plastic, and silicone, which have been used for other medical devices without any biocompatibility risk.
8. Conclusion
On the basis of the information provided in this Summary, LG Electronics believes LG BEAUTY LED MASK is substantially equivalent to legally commercialized predicate devices.