FAQ™ (302)
Device Facts
| Record ID | K242747 |
|---|---|
| Device Name | FAQ™ (302) |
| Applicant | Foreo, Inc. |
| Product Code | OAP · Physical Medicine |
| Decision Date | Dec 11, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
FAQ™ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-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
FAQ™ 302 is a handheld, rechargeable, square-shaped device for home use to promote hair growth. It utilizes 20 laser diodes (650±10nm) and 20 red LED beads (640-660nm) to deliver light therapy to the scalp. The user operates the device via a universal button to power on, select intensity, and initiate treatment; the device automatically powers off upon completion. It features Bluetooth connectivity to an FAQ App for treatment management. The device is powered by an internal non-detachable polymer lithium battery. By providing low-level light therapy, the device aims to stimulate hair follicles, potentially benefiting patients with androgenetic alopecia. The healthcare provider does not operate the device; it is intended for patient self-use at home.
Clinical Evidence
No clinical data. Bench testing only. Biocompatibility testing per ISO 10993-5, -10, and -23. Electrical safety and EMC testing per IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-57. Usability validation study with 15 adults confirmed safe and appropriate home use.
Technological Characteristics
Handheld, rechargeable device. 20 laser diodes (650±10nm) and 20 red LEDs (640-660nm). Internal polymer lithium battery (IEC 62133-2). Bluetooth connectivity. Class 3R laser classification per IEC 60825-1. Type BF channel isolation. Biocompatible materials per ISO 10993. Software level of concern: Minor.
Indications for Use
Indicated for males with androgenetic alopecia (Hamilton-Norwood IIa-V) and females with androgenetic alopecia (Ludwig-Savin I-II) with 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
Submission Summary (Full Text)
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December 11, 2024
Foreo Inc. % Danijela Domljanovic Consultant DD Consulting 401-4080 Living Arts Drive Mississauga, ON L5B4N# Canada
Re: K242747
Trade/Device Name: Faq™ (302) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: August 13, 2024 Received: September 12, 2024
Dear Danijela Domljanovic:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory
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assistance/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,
Digitally signed by YAN
YAN FU -S FU-S
Date: 2024.12.11 17:37:39
-05'00'
for Tanisha Hithe
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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# Indications for Use
510(k) Number (if known) K242747
Device Name FAOTM (302)
Indications for Use (Describe)
FAO™ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-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) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> ☒ </span> </div> |
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# 510(k) Summary
Date of Summary Revision: 28-Aug-2024
### Submitter's Identifications 1.
Submitter's Name: FOREO Inc. Address: 1525 E Pama Lane, Las Vegas, NV, USA ZIP Code: 89119 Contact Person: Evan Feldstein Contact Title: General Manager Contact E-mail Address: evan.feldstein@foreo.com Telephone: 419 376 1923
# 2. Correspondent's Identifications
Correspondent's Name: DD Consulting Address: 401-4080 Living Arts Drive, Mississauga, ON Canada ZIP Code: L5B 4N3 Contact Person: Danijela Domljanovic Contact Title: Regulatory Consultant Contact E-mail Address: regulatoryna@foreo.com Telephone: 647 928 6919
### Name of the Device 3.
Trade Name: FAQ Model: FAQ 302 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Common Name: Laser, Comb, Hair Regulatory Class: Class II Product Code: OAP Review Panel: General & Plastic Surgery
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# 4. The Predicate Devices
Primary Predicate: K210169 Hair Growth Device Primary Predicate: HairMax LaserComb 41
#### Device Description 5.
FAQ™ 302 is a handheld rechargeable square shaped device designed for improving hair growth with 20 laser diodes (wavelength 650±10m) and 20 RED LED beads (640-660nm) on the inside surface.
By pressing the universal button, the user can power the device on, start treatment and change the intensity by quick-pressing the button again. Once the treatment is complete, the device is turned off by pressing and holding the universal power button for 3 seconds.
The device can also be connected wirelessly via Bluetooth to an FAQ App in order to manage treatment. After the treatment is completed, the device automatically powers off.
The device uses a non-detachable polymer lithium battery for power supply in compliance with IEC 62133-2:2017+A1:2021 standard.
#### Intended Use of Device 6.
FAQ™ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
### Comparison with Predicate Device 7.
Table 1 Table Comparison of FAQ 302,LS-D601 (K210169) and HairMax LaserComb 41(K142573)
| Features | Subject Device | Predicate Device | Predicate Device | Remarks |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Regulatory Information | | | | |
| Device Name | FAQ™ 302 | Hair Growth Device | HairMax LaserComb 41 | / |
| 510(K) No. | K242747 | K210169 | K142573 | / |
| Regulation Number | 890.5500 | 890.5500 | 890.5500 | Same |
| Regulation name | Infrared Lamp | Infrared Lamp | Infrared Lamp | Same |
| Regulatory Class | II | II | II | Same |
| Product Code | OAP | OAP | OAP | Same |
| Indications for Use | FAQ™ 302 is indicated to<br>promote hair growth in<br>males with androgenetic<br>alopecia who have<br>Hamilton-Norwood<br>Classifications of IIa-V and<br>females with androgenetic<br>alopecia who have Ludwig-<br>Savin Classifications of I-II<br>and Fitzpatrick<br>Classification of Skin<br>Phototypes I to IV | The Hair Growth Device<br>is indicated to promote<br>hair growth in males<br>with androgenetic<br>alopecia who have<br>Hamilton-Norwood<br>Classifications of IIa-V<br>and females with<br>androgenetic alopecia<br>who have Ludwig-Savin<br>Classifications of1-II and<br>Fitzpatrick Classification<br>of Skin Phototypes I to<br>IV. | The HairMax LaserComb<br>41 is indicated to treat<br>Androgenetic alopecia<br>and promote hair growth<br>in males who have<br>Norwood Hamilton<br>Classifications of IIa to V<br>patterns of hair loss and<br>treat Androgenetic<br>alopecia and, promote<br>hair growth in females<br>who have Ludwig (Savin)<br>Scale I-4, II-1, II-2, or<br>frontal, both with<br>Fitzpatrick Skin Types I to<br>IV. | Same |
| Treatment<br>regimen | 8 minutes every other day | 25 minutes every other day | 3 minutes per use,<br>three times per week | Different<br>Note 1 |
| Use Environment | Home Use, over the<br>counter | Home Use, over the<br>counter | Home Use, over the<br>counter | Same |
| Power Source(s) | Internal rechargeable<br>Lithium battery | Power adapter | Internal rechargeable<br>Lithium battery | Different<br>Note 2 |
| Maximum charging time | 90 mins | Not applicable | Unknown | / |
| Electrical Power Source<br>Frequency (Nominal) | 60Hz | 60 Hz | 60 Hz | Same |
| Method of Channel<br>Isolation | Type BF | Type BF | Type BF | Same |
| Automatic Shut Off | Yes | Yes | Yes | Same |
| Mode of operation | Low-level laser diodes and<br>light emitting diodes | Low-level laser diodes and<br>light emitting diodes | Low-level laser diodes | Similar |
| Output mode | Continuous light | Continuous light | Continuous light | Same |
| Classification<br>according to IEC<br>60825-1 | Class 3R | Class 3R | Class 3R | Same |
| Energy of per<br>laser diode | <5mW | <5mW | <5mW | Same |
| Wavelength | Laser: 650±10nm<br>Red light LED: 640-660nm | Laser: 650-660nm<br>Red light LED: 640-660nm | Laser: 655±10nm | Similar |
| No. of light sources | Laser diodes: 20 lasers LED<br>diodes: 20 | Laser diodes: 26 lasers<br>LED diodes: 30 | Lasers LED diodes: 41 | Different<br>Note 3 |
| Treatment Area | Approx. 32cm2 | Unknown | Approx. 40cm2 | Different<br>Note 3 |
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www.foreo.com
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# Comparison in Details
## Note 1:
The proposed device treatment time is within the range of the predicate devices, and the treatment time of the proposed device does not raise new types of questions regarding safety and effectiveness.
## Note 2:
Though the power source is different the proposed device was tested to applicable electrical performance standards.
## Note 3:
The number of light sources, treatment area, wavelength, are similar to the predicate devices, and do not raise new types of questions with regard to safety and effectiveness.
# 8. Non-Clinical Tests Performed:
Clinical testing was considered not to be needed for this 510(k).
The following non-clinical testing was provided in this 510(k):
## Biocompatibility Testing
The subject device has been tested in compliance with the following standards and no additional risks concerning safety and effectiveness were noted;
- ISO 10993-5, Biological Evaluation of Medical Devices Part 5: Tests for InVitro Cytotoxicity ●
- ISO 10993-10, Biological Evaluation of Medical Devices Part 10: Tests for ● Irritation and Skin Sensitization.
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- ISO 10993-23 Biological evaluation of medical devices Part 23: Tests for irritation
# Electrical Safety and Electromagnetic Compatibility Testing
| Category | Standards | Standards Desc |
|----------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety | IEC<br>60601-1:2005/AMD1:2012/AMD2:20<br>20<br>CAN/CSA-C22.2 NO. 60601-1:14<br><br>AAMI 60601-1:2005 + AMD 1:2012 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance |
| | IEC 60601-1-6:2010+ AMD1:2013<br>+AMD2:2020 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential performance -<br>Collateral standard: Usability |
| | IEC 62366-1:2015+ AMD1:2020 | Medical devices - Part 1: Application of usability<br>engineering to medical devices |
| | IEC 60601-1-11:2015+AMD1:2020 | Medical electrical equipment - Part 1-11: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Requirements for medical electrical<br>equipment and medical electrical systems used in the<br>home healthcare environment |
| | IEC 60601-2-57: 2011 | Medical electrical equipment - Part 2-57: Particular<br>requirements for the basic safety and essential<br>performance of non-laser light source equipment intended<br>for therapeutic, diagnostic, monitoring and<br>cosmetic/aesthetic use |
| EMC | EN 60601-1-2: 2015<br>IEC 60601-1-2: 2014 (Edition 4) | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests |
| | IEC TR 60601-4-2:2016 | Medical electrical equipment - Part 4-2: Guidance and<br>interpretation - Electromagnetic immunity: performance<br>of medical electrical equipment and medical electrical<br>systems |
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## Software Verification and Validation
Software documentation consistent with Minor level of concern was submitted in this 510(k) per the FDA guidance document, "Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023. System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
## Cybersecurity
The cybersecurity risks associated with the FAQ™ 302 were evaluated as follows:
- Identification of assets, threats, and vulnerabilities;
- Assessment of impact of threats and vulnerabilities on device functionality and end user;
- Assessment of the likelihood of threats and of a vulnerability being exploited;
- Determination of risk levels and suitable mitigation strategies;
- Assessment of residual risk and risk acceptance criteria
The cybersecurity risk analysis performed, the controls identified, the comparison with the National Vulnerability Database, and the labeling information detailed with the Cybersecurity Assessment demonstrated that all risks associated with network capable interfaces of the device have been adequately mitigated.
# 9. Usability Study:
Usability validation testing was conducted with 15 adults enrolled to assure that the user could follow the directions we provided to safely use the device. Test results can be located in the "Usability validation report" that clearly indicate that the user instruction of FAQ 302 provides adequate guidance for the independent and appropriate home use for Laser and LED treatment.
#### Conclusion: 10.
Based on comparison of intended use and technical characteristics, the subject device FAQ 302 is similar to the legally marketed predicate LS-D601. Hardware and software verification and validation demonstrated the FAQ 302 met all performance specifications.
Any differences between the FAQ 302 and the predicate devices do not raise new types of questions of safety and effectiveness. Therefore, the FAQ 302 is substantially equivalent to the predicate one.
