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.

AI/ML Overview

This document is a 510(k) summary for the LG PRA.L DERMA LED MASK, outlining its substantial equivalence to a previously cleared device (LG BEAUTY LED MASK). The information provided focuses on the device's technical specifications and intended use for wrinkle treatment, rather than an AI/ML algorithm's performance.

Therefore, many of the specific criteria related to AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable or not explicitly stated in this type of FDA submission for a physical device like an LED mask.

However, I can extract the relevant information regarding the device's performance data and acceptance criteria based on the available text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device, specifically that changes in the modified device (LG PRA.L DERMA LED MASK) do not raise new questions of safety or effectiveness. The performance tests conducted are primarily non-clinical, focusing on confirming functionality and safety standards.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence: Same indications for use as predicate.	Met. "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." This matches the predicate's intended use.
Material Equivalence: Same or biocompatible materials.	Met. "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." The materials list is identical to the predicate device.
LED Emission Equivalence: Same wavelengths and power density.	Met. "RED (637 nm) and IR (854 nm)" for wavelengths, and "25 mW/cm² total" for LED power density are identical to the predicate.
Treatment Parameters Equivalence: Same treatment time/frequency.	Met. "9 minutes daily 5 days per week for 8 weeks" is identical to the predicate.
Safety and Performance Standards Compliance: Conformity to recognized standards.	Met. Non-clinical tests performed: - Measurement of wavelength, average output power, and total irradiance. - IEC 60601-1 (Basic safety and essential performance). - IEC 60601-1-2 (Electromagnetic disturbances). - IEC 62471-1 (Optical hazard). - ISO 14971 (Risk management). - IEC 62366-1 (Usability). The "performance test shown that there is no technical characteristic difference in the modified device." and "The external design changes do not raise any concerns regarding the device performance and safety."
No New Safety/Effectiveness Concerns: Differences (like number of LEDs) do not introduce new risks.	Met. The primary difference noted is the number of LEDs (160 in proposed vs. 120 in predicate). The submission implies that despite this difference in component count, the overall power density and intended effect remain equivalent and safe, as indicated by the "LED power: 25 mW/cm² total" being the same for both devices.

Regarding Specific AI/ML-related Questions:

Sample size used for the test set and the data provenance:
- Not applicable/Not specified. This is a physical device submission, not an AI/ML algorithm. Performance evaluation is based on non-clinical engineering tests (e.g., optical power, safety standards) and comparison of specifications to a predicate device, not a data-driven test set of patient images/records.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated outcomes or expert annotations. For this device, "ground truth" is established through engineering specifications, compliance with medical device standards, and the safety/efficacy profile of the predicate device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a standalone personal cosmetic device for wrinkle treatment, not an AI-assisted diagnostic or interpretation tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is electro-optical hardware with a fixed treatment protocol, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this medical device's clearance is primarily based on engineering specifications, compliance with recognized safety and performance standards (e.g., IEC, ISO), and demonstration of substantial equivalence to a legally marketed predicate device. For wrinkle treatment devices, the efficacy (reduction of wrinkles) in clinical studies would typically serve as the "outcomes data" ground truth, but for a 510(k) based on substantial equivalence to a similar device, direct clinical outcome studies are often not required if the changes are minor and do not impact safety or efficacy. The document explicitly states "The performance test shown that there is no technical characteristic difference in the modified device." implying the predicate's established performance serves as the reference.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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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

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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 byNeil R Ogden -S
Ogden -S	Date: 2019.01.2215:41:21 -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

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LG PRA.L DERMA LED MASK

Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See 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.

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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 KimBT Solutions, Inc.904, Eonju-ro 86-gil 5,Gangnam-gu, Seoul, 06210, Republic of KoreaTel: +82-2-538-9140 Fax: +82-2-539-9140Email: 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:

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.

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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 isan over the counter device that isintended for the use in thetreatment of full face wrinkles.	The LG PRA.L DERMA LEDMASK is an over the counterdevice that is intended for the usein the treatment of full facewrinkles.	YES
Materials	Mask frame: PCEye frame: PPEye shield: SiliconeViewing shield: ABS plasticController frame: PPAdaptor frame: PPCradle frame: PP	Mask frame: PCEye frame: PPEye shield: SiliconeViewing shield: ABS plasticController frame: PPAdaptor frame: PPCradle frame: PP	YES

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LG PRA.L DERMA LED MASK

Dimension(mm)	LED Mask: 180 x 214.5 x 92.4Controller: 41 x 31 x 103Adaptor: 87 x 44 x 28Cradle: 190 x 222 x 156	LED Mask: 178.8 x 225 x 89Controller: 40 x 30 x 110Adaptor: 87x 44 x 28Cradle: 180 x 229 x 167.8	YES
Net weight(g)	LED Mask: 207 gController: 82 gAdaptor: 75 gCradle: 375 g	LED Mask: 225 gController: 84 gAdaptor: 75 gCradle: 380 g	YES
LEDEmission	RED (637 nm) and IR (854 nm)	RED (637 nm) and IR (854 nm)	YES
Number ofLEDs	Total 120 LEDs (60 of them arefor 637 nm and the rest 60 ofthem are for 854 nm)	Total 160 LEDs (80 of them arefor 637 nm and the rest 80 ofthem are for 854 nm)	NO
LED power	25 mW/cm² total	25 mW/cm² total	YES
Electronicpower	Input: AC 100V ~ 240VFrequency: 50Hz/60HzOutput: 5V 2A	Input: AC 100V ~ 240VFrequency: 50Hz/60HzOutput: 5V 2A	YES
Battery	Lithium-ion	Lithium-ion	YES
Treatmenttime	9 minutes daily5 days per week for 8 weeks	9 minutes daily5 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.

Regulation Number and Section

§ 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.