(148 days)
No
The summary describes a device that uses laser diodes and LEDs for hair growth. There is no mention of AI or ML in the device description, intended use, or performance studies. The device functionality appears to be based on light emission and basic control features.
Yes
The device is indicated to "promote hair growth in males with androgenetic alopecia" and "females with androgenetic alopecia," which is a medical condition. Therefore, it is intended for therapeutic use.
No
The device is intended to promote hair growth by emitting light onto the scalp, which is a therapeutic function, not a diagnostic one. It does not analyze or interpret any patient data to identify a condition or disease.
No
The device description explicitly states it is a "dome shaped helmet with laser diodes and LEDs on the inside surface" and mentions a "controller" and "charging cradle," indicating significant hardware components beyond just software.
Based on the provided information, the LG Pra.L Derma LD Scalp Care is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The LG Pra.L Derma LD Scalp Care is a device that applies light energy directly to the scalp to promote hair growth. It does not analyze any biological samples.
- Intended Use: The intended use is to promote hair growth in individuals with androgenetic alopecia, which is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and how it delivers light therapy. There is no mention of sample collection or analysis.
Therefore, the LG Pra.L Derma LD Scalp Care falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
OAP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
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
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 performed. Other performance, such as safety of laser product, electromagnetic compatibility and electrical safety, etc, were tested using following consensus standards:
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
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.(b)
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.
0
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
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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
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
6. 510(k) Summary
6.1 General Information
| Applicant/Submitter: | LG Electronics, Inc. |
|---|---|
| Address: | 222 LG-ro Jinwi-myeon, |
| Pyeongtaek-Si, Gyeonggi-do, 17709 | |
| Rep. of Korea (South Korea) | |
| Tel: +82-2-3777-5497 | |
| Contact Person: | Do Hyun Kim, BT Solutions, Inc. |
| Address: | Unit 904, Eonju-ro 86gil 5, |
| Gangnam-gu, Seoul 06210, Korea. | |
| Tel: +82-2-538-9140 | |
| Email: smanager@btsolutions.co.kr | |
| 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 | ||
| number | 890.5500 | 890.5500 |
| Classification | Class II | Class II |
| 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 | IllumiFlow is indicated to promote hair | |
| growth in males with androgenic alopecia | ||
| who have Norwood-Hamilton | ||
| classifications of IIa to V or females with | ||
| androgenic alopecia who have Ludwig- | ||
| Savin Classification of I-II and both with |
4
| | I-II and Fitzpatrick Classification of Skin
Phototypes I to IV. | Fitzpatrick Skin Phototypes I to IV. |
|----------------------------------|--------------------------------------------------------------------|--------------------------------------|
| Intended user | Both sex | Both sex |
| Type of use | OTC | OTC |
| Technological
characteristics | | |
| Mode of operation | Low-level laser diodes and light emitting
diodes | Low-level laser diodes |
| Wavelength | LD: 650 ~ 667nm
LED: 645 ~ 665nm | 650 nm |
| No. of light
source | 250 | 272 |
| Power output | 5 mW per light output point | 5 mW per light output point |
| Usage duration | | |
| Treatment
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:
5
- -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.