(26 days)
Not Found
No
The description focuses on the physical components and light emission, with no mention of AI/ML terms or functionalities like data analysis, learning, or adaptive behavior.
Yes
The device is intended for the treatment of full face wrinkles, which is a therapeutic purpose.
No
The device is intended for the treatment of full face wrinkles using LED light, not for diagnosing any condition.
No
The device description explicitly details hardware components including a mask with LEDs, a controller, and a power supply unit. The performance studies also focus on hardware characteristics like wavelength, power, and irradiance, and reference hardware-related standards (IEC 60601-1, IEC 60601-1-2, IEC 62471-1).
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" using LED light. This is a therapeutic application, not a diagnostic one.
- Device Description: The device emits light onto the face for treatment. It does not analyze biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of any components or processes related to analyzing biological samples or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The LG PRA.L DERMA 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 PRA.L DERMA 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. The LG PRA.L DERMA LED MASK includes 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 PRA.L DERMA 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 PRA.L DERMA LED MASK has protective eye-shield 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
full face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter 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 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 PRA.L DERMA 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.
K170984 LG BEAUTY LED MASK
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 shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
LG Electronics, Inc. % Do-Hyun Kim CEO BT Solutions. Inc. 904. Eonju-ro 86-gil 5. Seoul, 06210 Kr
January 22, 2019
Re: K183671
Trade/Device Name: LG PRA.L Derma 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: December 21, 2018 Received: December 27, 2018
Dear Do-Hyun 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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
| Neil R | Digitally signed by
Neil R Ogden -S |
|----------|----------------------------------------|
| Ogden -S | Date: 2019.01.22
15:41:21 -05'00' |
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
LG PRA.L DERMA LED MASK
Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | N/A K183671 |
Device Name LG PRAL DERMA LED MASK
Indications for Use (Describe)
The LG PRA.L DERMA 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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
5. 510(k) Summary
Date: December 21, 2018
| 1. Applicant / Submitter: | LG Electronics, Inc.
222 LG-ro, Jinwi-myeon, Pyeongtaek-si,
Gyeonggi-do, 17709, Republic of Korea |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submission Correspondent: | Do-Hyun Kim
BT Solutions, Inc.
904, Eonju-ro 86-gil 5,
Gangnam-gu, Seoul, 06210, Republic of Korea
Tel: +82-2-538-9140 Fax: +82-2-539-9140
Email: smanager@btsolutions.co.kr |
3. Device Name and Code:
| Device Name: | LG PRA.L DERMA LED MASK |
|---|---|
| Trade Name: | LG PRA.L DERMA 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) |
4. Predicate Device:
- Primary Predicate Device: K170984 LG BEAUTY LED MASK by LG Electronics, Inc. ●
5. Device Description:
The LG PRA.L DERMA 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. The LG PRA.L DERMA LED MASK includes 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 PRA.L DERMA 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 PRA.L DERMA LED MASK has protective eye-shield which blocks light energy from LEDs.
6. Indication for use:
The LG PRA.L DERMA LED MASK is an over the counter device that is intended for the use in the treatment of full face wrinkles.
4
LG PRA.L DERMA LED MASK
510(k) Summary
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 PRA.L DERMA 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.
8. Substantial Equivalence:
The LG PRA.L DERMA LED MASK is an over the counter device that is intended for the use in the treatment of full face wrinkles. The subject device has the same device characteristics as the predicate (unmodified) device. They have the same intended use, material, and use concept and employ the same manufacturing processes. The differences are in shape, dimensions and LED total number. The performance test shown that there is no technical characteristic difference in the modified device. The external design changes do not raise any concerns regarding the device performance and safety. Therefore, LG PRA.L DERMA LED MASK is substantially equivalent to the legally marketed predicate/unmodified device.
| Predicate/Unmodified Device | Proposed/Modified Device | SE | |
|---|---|---|---|
| Manufacturer | LG Electronics, Inc. | LG Electronics, Inc. | - |
| Device Name | LG BEAUTY LED MASK | LG PRA.L DERMA LED MASK | - |
| 510(K) # | K170984 | - | - |
| Class | 2 | 2 | YES |
| Product Code | OHS | OHS | YES |
| 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. | The LG PRA.L DERMA LED | ||
| MASK is an over the counter | |||
| device that is intended for the use | |||
| in the treatment of full face | |||
| wrinkles. | YES | ||
| Materials | Mask frame: PC | ||
| Eye frame: PP | |||
| Eye shield: Silicone | |||
| Viewing shield: ABS plastic | |||
| Controller frame: PP | |||
| Adaptor frame: PP | |||
| Cradle frame: PP | Mask frame: PC | ||
| Eye frame: PP | |||
| Eye shield: Silicone | |||
| Viewing shield: ABS plastic | |||
| Controller frame: PP | |||
| Adaptor frame: PP | |||
| Cradle frame: PP | YES |
5
LG PRA.L DERMA LED MASK
| Dimension
(mm) | LED Mask: 180 x 214.5 x 92.4
Controller: 41 x 31 x 103
Adaptor: 87 x 44 x 28
Cradle: 190 x 222 x 156 | LED Mask: 178.8 x 225 x 89
Controller: 40 x 30 x 110
Adaptor: 87x 44 x 28
Cradle: 180 x 229 x 167.8 | YES |
|---------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----|
| Net weight
(g) | LED Mask: 207 g
Controller: 82 g
Adaptor: 75 g
Cradle: 375 g | LED Mask: 225 g
Controller: 84 g
Adaptor: 75 g
Cradle: 380 g | YES |
| LED
Emission | RED (637 nm) and IR (854 nm) | RED (637 nm) and IR (854 nm) | YES |
| Number of
LEDs | Total 120 LEDs (60 of them are
for 637 nm and the rest 60 of
them are for 854 nm) | Total 160 LEDs (80 of them are
for 637 nm and the rest 80 of
them are for 854 nm) | NO |
| LED power | 25 mW/cm² total | 25 mW/cm² total | YES |
| Electronic
power | Input: AC 100V ~ 240V
Frequency: 50Hz/60Hz
Output: 5V 2A | Input: AC 100V ~ 240V
Frequency: 50Hz/60Hz
Output: 5V 2A | YES |
| Battery | Lithium-ion | Lithium-ion | YES |
| Treatment
time | 9 minutes daily
5 days per week for 8 weeks | 9 minutes daily
5 days per week for 8 weeks | YES |
510(k) Summary
9. Conclusion
On the basis of the information provided in this Summary, LG Electronics believes LG PRA.L DERMA LED MASK is substantially equivalent to the legally marketed predicate/unmodified device.