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.

AI/ML Overview

This document is a 510(k) premarket notification for the "LG Beauty LED Mask," seeking clearance from the FDA. It does not contain a study proving the device meets specific acceptance criteria based on clinical performance metrics (like sensitivity, specificity, accuracy, or effect sizes for human readers). Instead, it primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing.

Therefore, many of the requested details about acceptance criteria, clinical study design, ground truth establishment, and multi-reader multi-case studies cannot be extracted from this document, as they were not performed or reported in this submission for this type of device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present clinical performance data in the form of a table with specific acceptance criteria (e.g., minimum sensitivity, specificity) and corresponding device performance. Instead, substantiation for this OTC (Over-The-Counter) device focuses on technical equivalence to predicate devices and non-clinical testing for safety and basic function.

Acceptance Criteria (Type)	Reported Device Performance (Details)
Technical Equivalence	Demonstrated by comparing LED emission wavelengths, power, and treatment time to predicate devices (K163329 and K133896).
LED Emission (RED)	LG: 637 nm
LED Emission (IR)	LG: 854 nm
LED Power (total)	LG: 25 mW/cm²
Treatment Time	LG: 9 minutes daily, 5 days per week for 8 weeks
Non-Clinical Testing (Safety & Function)	Tested according to recognized consensus standards.
Basic Safety & Essential Performance	IEC 60601-1 (Tested and evaluated)
Electromagnetic Disturbances	IEC 60601-1-2 (Tested and evaluated)
Optical Hazard	IEC 62471-1 (Evaluated)
Risk Management	ISO 14971 (Recorded)
Usability	IEC 62366-1 (Documented)
Biocompatibility	"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." (Implied acceptance based on material commonality)

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a clinical test set with a sample size for evaluating the device's efficacy in treating wrinkles. The "tests" mentioned are non-clinical (e.g., measurement of wavelength, power output, safety tests against standards).

Sample Size: Not applicable for clinical testing as described here.
Data Provenance: Not applicable for clinical data. The non-clinical tests were likely conducted in a controlled lab environment. The submitter is LG Electronics, Inc. from Republic of Korea (South Korea).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This type of information would be relevant for devices involving image interpretation or diagnostic accuracy studies, which is not the primary focus or justification described for this OTC LED mask.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring ground truth adjudication is described.

5. 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 an LED mask for wrinkle reduction, not an AI-assisted diagnostic tool requiring MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithmic device. The device's function is direct light emission for treatment.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical efficacy. The "ground truth" for the non-clinical tests refers to the established standards (e.g., IEC, ISO) and the device's measured physical properties (e.g., measured wavelength, power output).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning/AI device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not a machine learning/AI device.

Summary

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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

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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

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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 andWrinkle 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

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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 WrinkleMask 28 and WrinkleMask 72	Rejuvalite MD	LG BEAUTY LEDMASK
510(k)number	K163329	K133896	N/A
Product Code	OHS	OHS	OHS
Intended Use	The Pulsaderm WrinkleMasks 28 and 72 areintended for the use inthe treatment of facialwrinkles and for peoplewith Fitzpatrick SkinTypes I, II and III	The Rejuvalite MD isan over-the-counterdevice intended for theuse in the treatment offull-face wrinkles	The LG BEAUTYLED MASK is anover the counterdevice that isintended for the usein the treatment offull face wrinkles.
LEDemission	Emission of red (620-630 nm) and IR (850nm)	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
Treatmenttime	15 minutes everyday	3 minutes daily5 days per week for 8weeks	9 minutes daily5 days per week for 8weeks

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.

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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.

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.