LG Pra. L Derma LD Scalp Care

K200464 · Lg Electronics.Inc · OAP · Jul 23, 2020 · Physical Medicine

Device Facts

• Record ID: K200464
• Device Name: LG Pra. L Derma LD Scalp Care
• Applicant: Lg Electronics.Inc
• Product Code: OAP · Physical Medicine
• Decision Date: Jul 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The LG Pra.L Derma LD Scalp Care is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

Device Story

Dome-shaped helmet device for home use; treats androgenetic alopecia via low-level light therapy. Input: electrical power; Transformation: 250 light sources (laser diodes 650-667nm; LEDs 645-665nm) deliver 5mW per point to scalp; Output: light energy absorbed by scalp. Operated by patient via controller (power, mode selection, treatment start/pause) or smartphone app via Bluetooth. Device features automatic power-off post-treatment and battery charging cradle. Benefits patient by promoting hair growth; healthcare provider does not interact with device output.

Clinical Evidence

Bench testing only. Performance evaluated via wavelength, output power, and irradiance measurements. Safety validated per ES 60601-1, IEC 60601-1-2, and IEC 60825-1. Usability study with 34 participants demonstrated ability to understand labeling and safely operate the device.

Technological Characteristics

Dome-shaped helmet; 250 light sources (laser diodes 650-667nm, LEDs 645-665nm); 5mW output per point. Connectivity: Bluetooth to smartphone app. Standards: ES 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety), ISO 14971 (risk management), ISO 62366-1 (usability).

Indications for Use

Indicated for males with androgenetic alopecia (Hamilton-Norwood IIa-V) and females with androgenetic alopecia (Ludwig-Savin I-II, Fitzpatrick Skin Phototypes I-IV) to promote hair growth.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• IllumiFlow Laser Cap (K162071)

Reference Devices

• iGrow II Hair Growth System (K140931)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in a smaller font below.

July 23, 2020

LG Electronics, Inc. % Do-Hyun Kim CEO BT Solutions, Inc. 904-ho, Eonju-ro 86-gil 5 Gangnam-gu Seoul, 06210 Korea, Republic Of

Re: K200464

Trade/Device Name: LG Pra. L Derma LD Scalp Care Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: February 24, 2020 Received: February 26, 2020

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Colin Kejing Chen 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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K200464

Device Name LG Pra.L Derma LD Scalp Care

Indications for Use (Describe)

The LG Pra.L Derma LD Scalp Care is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 6. 510(k) Summary

# 6.1 General Information

| Applicant/Submitter: | LG Electronics, Inc. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Address: | 222 LG-ro Jinwi-myeon,<br>Pyeongtaek-Si, Gyeonggi-do, 17709<br>Rep. of Korea (South Korea)<br>Tel: [phone] |
| Contact Person: | Do Hyun Kim, BT Solutions, Inc. |
| Address: | Unit 904, Eonju-ro 86gil 5,<br>Gangnam-gu, Seoul 06210, Korea.<br>Tel: [phone]<br>Email: [e-mail] |
| Preparation Date: | February 24, 2020 |

# 6.2 Device Name and Code

| Device Trade Name: | LG Pra.L Derma LD Scalp Care |
|----------------------|-------------------------------------------------|
| Model Name: | HGN1 |
| Common Name: | Lamp, non-heating, for promotion of hair growth |
| Classification Name: | Infrared Lamp |
| Product Code: | OAP |
| Regulation Number: | 890.5500 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery (ODE) |

# 6.3 Technical Characteristics in Comparison to Predicate Devices

| | Proposed Device | K162071 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | LG Electronics Inc. | EGlobal, LLC |
| Product name | LG Pra.L Derma LD Scalp Care | IllumiFlow Laser Cap |
| Product code | OAP | OAP |
| Regulation<br>number | 890.5500 | 890.5500 |
| Classification | Class II | Class II |
| Intended Use | The LG Pra.L Derma LD Scalp Care is<br>indicated to promote hair growth in males<br>with androgenetic alopecia who have<br>Hamilton-Norwood Classifications of IIa-V<br>and females with androgenetic alopecia<br>who have Ludwig-Savin Classifications of | IllumiFlow is indicated to promote hair<br>growth in males with androgenic alopecia<br>who have Norwood-Hamilton<br>classifications of IIa to V or females with<br>androgenic alopecia who have Ludwig-<br>Savin Classification of I-II and both with |

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| | I-II and Fitzpatrick Classification of Skin<br>Phototypes I to IV. | Fitzpatrick Skin Phototypes I to IV. |
|----------------------------------|--------------------------------------------------------------------|--------------------------------------|
| Intended user | Both sex | Both sex |
| Type of use | OTC | OTC |
| Technological<br>characteristics | | |
| Mode of operation | Low-level laser diodes and light emitting<br>diodes | Low-level laser diodes |
| Wavelength | LD: 650 ~ 667nm<br>LED: 645 ~ 665nm | 650 nm |
| No. of light<br>source | 250 | 272 |
| Power output | 5 mW per light output point | 5 mW per light output point |
| Usage duration | | |
| Treatment<br>duration | 18 minutes or 27 minutes | 30 minutes |

### LG Pra.L Derma LD Scalp Care 510(k) Summary

Reference Device: Apira Science, Inc's iGrow II Hair Growth System (K140931).

## 6.4 Device Description

The LG Pra.L Derma LD Scalp Care utilizes a combination of laser diodes and light-emitting diodes (LEDs). 5-milliwatt laser diodes emit light from a range of wavelengths of about 650 nm to 667 nm, which is combined with light from 5 milliwatt LEDs emitting wavelengths from about 645nm to 665 nm. The combined light is absorbed by the scalp.

The LG Pra.L Derma LD Scalp Care is a dome shaped helmet with laser diodes and LEDs on the inside surface. By connecting a controller, the user can power the device on and off, start and pause treatment, and change the care mode. In addition, there is a charging cradle to place the controller in to charge the battery, and the status of the battery is displayed on the controller's indicator. The device can also be connected wirelessly via Bluetooth to a Smartphone App in order to manage treatment. After a treatment is completed, the LG Pra.L Derma LD Scalp Care device can automatically power off the laser, LEDs and controllers.

## 6.5 Indications / Intended Use

The LG Pra.L Derma LD Scalp Care is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

## 6.6 Performance Data

Non-clinical tests: Measurement of wavelength, average output power, and total irradiance (power density, in units of J/cm2) of treatment LEDs and LDs were Other performance, such as safety of laser product, electromagnetic performed. compatibility and electrical safety, etc, were tested using following consensus standards:

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- -Basic safety and essential performance of the LG Pra.L Derma LD Scalp Care is tested and evaluated according to the FDA-recognized consensus standard, ES 60601-1.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2.
- -Safety of laser product is evaluated in accordance with IEC 60825-1: 2014.
- Risk management was recorded by referring to ISO 14971. -
- -Usability was documented by referring to ISO 62366-1.

Testing of 34 participants was conducted showing that the participants were able to understand the user manual and box labeling and were able to safely and effectively use the device.

#### 6.7 Conclusions

The proposed device uses similar or identical technology as the predicate device and has the same intended use. Based upon the predicted overall performance characteristics for LG Pra.L Derma LD Scalp Care, LG Electronics, Inc. believes that the technological characteristics of LG Pra.L Derma LD Scalp Care do not raise new types of questions regarding its safety and efficacy for its intended use compared with the predicate device. On the basis of the information provided in this 510(k), LG Electronics, Inc. believes that the LG Pra.L Derma LD Scalp Care is substantially equivalent to the predicate device.