REVIAN RED

K173729 · Photonmd, Inc. · OAP · Feb 28, 2018 · Physical Medicine

Device Facts

• Record ID: K173729
• Device Name: REVIAN RED
• Applicant: Photonmd, Inc.
• Product Code: OAP · Physical Medicine
• Decision Date: Feb 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

REVIAN RED is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

Device Story

REVIAN RED is a wearable, hands-free, textile cap for home-based, OTC treatment of androgenetic alopecia. The device uses 119 red LEDs to deliver Modulated Light Therapy (MLT) to the scalp. It is powered by a rechargeable lithium polymer battery and controlled via a wireless Bluetooth connection to a mobile application. The system includes driver electronics and a flexible printed circuit board. The mobile app provides treatment reminders, messages, and controls the 10-minute daily treatment session. The device includes safety features that pause therapy if the user's head moves outside the radiation zone and automatically powers down after the 10-minute session. The healthcare provider does not operate the device; it is for patient self-use. The device aims to promote hair growth through light therapy.

Clinical Evidence

No clinical trial data was submitted. Substantial equivalence was demonstrated through non-clinical performance testing, including electrical safety (IEC 60601-1, IEC 60601-1-2, ANSI/AAMI HA60601-1-11:2015), photobiological safety (IEC 62471), and biocompatibility (ISO 10993-1). Human factors evaluation was conducted per ANSI/AAMI/IEC 62366-1 and 60601-1-6.

Technological Characteristics

Wearable textile cap with 119 red LEDs (620-660 nm). Powered by rechargeable lithium polymer battery. Connectivity via Bluetooth to mobile application. Safety features include automatic power-down and radiation zone monitoring. Biocompatible materials per ISO 10993-1. Conforms to IEC 60601-1, IEC 60601-1-2, ANSI/AAMI HA60601-1-11:2015, IEC 60601-2-57, and IEC 62471.

Indications for Use

Indicated for males (Norwood-Hamilton IIa-V) and females (Ludwig-Savin I-1 to I-4, II-1, II-2 or frontal) with Androgenetic Alopecia and Fitzpatrick Skin Types 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

• iHelmet Hair Growth System (K162782)
• HairMD (K152019)
• HairMax LaserComb 82 (K142573)
• LH80 PRO (K122950)

Submission Summary (Full Text)

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February 28, 2018

PhotonMD. Inc Mr. William Knape Senior Director, Regulatory Quality and Clinical Affairs 627 Davis Drive, Suite 400 Morrisville, North Carolina 27560

Re: K173729

Trade/Device Name: Revian Red Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: December 4, 2017 Received: December 6, 2017

Dear Mr. Knape:

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 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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K173729

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ([e-mail]) or phone [phone] or 301-796-7100).

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) K173729

Device Name REVIAN RED

#### Indications for Use (Describe)

REVIAN RED is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - 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>☑</div> |

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PhotonMD

#### 510(K) Summary 1

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 890.5500.

#### 1.1 Submitter Information:

| Sponsor: | PhotonMD, Inc.<br>627 Davis Drive, Suite 400<br>Morrisville, NC 27560 |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | William A. Knape<br>Senior Director of Regulatory, Quality and Clinical Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Submission Date: | December 4, 2017 |

# 1.2 Subject Device Information

| Trade/Proprietary Name: | REVIAN RED (Model 101) |
|-------------------------|-----------------------------------|
| Common/Usual Name: | Lamp for Promotion of Hair Growth |
| Regulation Name: | Infrared Lamp per 21 CFR 890.5500 |
| Review Panel: | General & Plastic Surgery |
| Product Code: | OAP (laser, comb, hair) |
| Regulation Number: | 21 CFR 890.5500 |
| Regulatory Class: | Class 2 |

#### 1.3 Predicate Device Information

| Predicate Devices: | Device | 510(k)<br>Number | Manufacturer |
|--------------------|----------------------------|------------------|-------------------------|
| | iHelmet Hair Growth System | K162782 | Slinph Technologies |
| | HairMD | K152019 | Trophy Skin |
| | HairMax LaserComb 82 | K142573 | Lexington International |
| | LH80 PRO | K122950 | Theradome |

# 1.4 Device Description

REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile application to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. REVIAN RED is a system comprised of a wearable soft textile Cap using driver electronics, a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board. REVIAN RED is designed as an over-the-counter (OTC) home-based device to treat

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Image /page/4/Picture/0 description: The image shows the logo for PhotonMD. The word "Photon" is in gray, with a colorful atom symbol in the middle of the word. The letters "MD" are in green.

#### February 26, 2018 Traditional 510(k) Premarket Notification

the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.

# 1.5 Indications for Use

The REVIAN RED device is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

# 1.6 Performance Test Summary

No clinical trial data for the REVIAN RED System was submitted for this 510(k). Nonclinical performance testing to demonstrate substantial equivalence to the predicate device included evaluation to IEC 60601-1 and 60601-1-2 to confirm the device's electrical safety and electromagnetic compatibility and conformance with ANSI/AAMI HA60601-1-11:2015, IEC 60601-2-57 (Edition 1.0), and IEC 62471 (Edition 1.0). Biocompatibility testing of the Cap per ISO 10993-1 confirmed no effects of the applied parts were noted for cytotoxicity, skin irritation or skin sensitization. Performance verification and validation testing demonstrates REVIAN RED meets user needs and design inputs and met requirements for its intended use.

#### Studies Related to Human Factors Evaluation

Human factors evaluation of REVIAN RED was tested following ANSVAAMI/IEC 62366-1 and 60601-1-6 standards. The study protocol was designed to evaluate representative users of the device under expected use conditions during simulated and actual use of the device. The Human Factors Engineering and Usability Engineering process involved several methodologies, including observational user research, formative and summative user testing.

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Image /page/5/Picture/0 description: The image shows the logo for PhotonMD. The word "Photon" is in gray, with a colorful graphic in the middle of the word. The letters "MD" are in green. The logo is simple and modern.

#### February 26, 2018 Traditional 510(k) Premarket Notification

### 1.7 Comparison to Predicate Devices

REVIAN RED has similar technological characteristics as the iHelmet Hair Growth System (K162782) including wavelength, light energy delivery method, mobile app interface with interactive audible timers and intended use. REVIAN RED is also similar technologically to the other helmet designed devices; with HairMD (K152019) and LH80 PRO (K122959) having fewer diodes (51 laser diodes/LEDS and 80 laser diodes, respectively) and longer treatment regimens of 20 minutes.

| 510(k) # | K173729 | K162782 | K152019 | K142573 | K122950 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | REVIAN RED | iHelmet Hair<br>Growth System<br>(LTD200S) | HairMD | HairMax<br>LaserComb 82<br>(HMLC 82) | LH80 PRO |
| Company | PhotonMD, Inc. | Slinph<br>Technologies | Trophy Skin | Lexington<br>International | Theradome |
| Product Code | OAP | OAP | OAP | OAP | OAP |
| Rx/OTC | OTC | OTC | OTC | OTC | OTC |
| Intended Use/<br>Indications for<br>Use | Treat<br>Androgenetic<br>Alopecia and<br>promote hair<br>growth in males<br>who have<br>Norwood-<br>Hamilton<br>Classification IIa<br>to V patterns of<br>hair loss and to<br>treat Androgenetic<br>Alopecia and<br>promote hair<br>growth in females<br>who have<br>Ludwig-Savin<br>scale I-1 to I-4,<br>II-1, II-2 or frontal<br>patterns of hair<br>loss; both with<br>Fitzpatrick Skin<br>Types I to IV | Promote hair<br>growth in females<br>with<br>Androgenetic<br>Alopecia who<br>have Ludwig-<br>Savin<br>Classification of<br>I-II, in males with<br>Androgenetic<br>Alopecia who<br>have Norwood<br>Hamilton<br>Classifications of<br>IIa-V and for<br>both, Fitzpatrick<br>Classification of<br>Skin Phototypes I<br>- IV. | Promote hair<br>growth in females<br>with<br>Androgenetic<br>Alopecia who<br>have Ludwig-<br>Savin<br>Classification of<br>I-II, in males with<br>Androgenetic<br>Alopecia who<br>have Norwood<br>Hamilton<br>Classifications of<br>IIa-V and for<br>both, Fitzpatrick<br>Classification of<br>Skin Phototypes I<br>- IV. | Treat<br>Androgenetic<br>Alopecia and<br>promote hair<br>growth in males<br>who have<br>Norwood<br>Hamilton<br>Classification<br>IIa to V patterns<br>of hair loss and<br>treat<br>Androgenetic<br>Alopecia and,<br>promote hair<br>growth in females<br>who have Ludwig<br>(Savin) scale I-4,<br>II-1, II-2 or<br>frontal, both with<br>Fitzpatrick skin<br>types I to IV. | Treat<br>Androgenetic<br>Alopecia, to<br>promote hair<br>growth in<br>females with<br>female pattern<br>hair loss (FPHL)<br>on the Ludwig<br>and Savin Hair<br>Loss Scale I-II,<br>Fitzpatrick Skin-<br>Types I to IV. |
| Wearable<br>Mounting | Textile Cap | Helmet | Helmet | Head Band | Helmet |
| Wave-Length(s) | 620 - 660 nm | 650 nm ±10nm | 650 nm | 655 nm ±10nm | 678 nm |
| Visible Light<br>source | 119 Red<br>LEDs | 200 Red Laser<br>Diodes | 21 Red Laser<br>Diodes and<br>30 Red LEDs | 82 Red Laser<br>Diodes | 80 Red Laser<br>Diodes |
| Battery | Lithium<br>Polymer | Lithium<br>Polymer | Powered by 120V<br>Wall Plug | Lithium<br>Polymer | Lithium<br>Polymer |

#### Table 1 – Summary of Predicate Devices Compared to REVIAN RED

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Image /page/6/Picture/0 description: The image shows the logo for PhotonMD. The word "Photon" is in gray, with a graphic of colorful people surrounding a white sphere in the middle of the word. The letters "MD" are in green. The logo is simple and modern.

#### February 26, 2018 Traditional 510(k) Premarket Notification

#### Table 1 - Summary of Predicate Devices Compared to REVIAN RED (cont'd)

| 510(k) # | K173729 | K162782 | K152019 | K142573 | K122950 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Treatment Time | Every day<br>10 mins | Every other day<br>20-35 mins | Every other day<br>20 mins | 3 times / week<br>90 seconds | 2 times / week<br>20 mins |
| Digital Mobile<br>Controller | Yes | Yes | No | No | No |
| Restrictions on<br>Daily Irradiance | Yes, daily limit<br>for treatments | No | No | No | No |
| Other Design<br>Characteristics | Cap pauses<br>therapy if subject's<br>head moves<br>outside zone of<br>radiation; after<br>completion of<br>treatment, unit<br>powers down,<br>limits daily<br>treatment to 10<br>mins, and<br>provides treatment<br>reminders and<br>messages via<br>mobile app<br>controller | Helmet pauses<br>therapy if<br>subject's head<br>moves outside<br>zone of radiation;<br>after completion<br>of time, unit<br>powers down and<br>audible beep. | Helmet pauses<br>therapy if<br>subject's head<br>moves outside<br>zone of radiation;<br>after completion<br>of time, unit<br>powers down and<br>audible beep. | Vibrate so user<br>can move to the<br>next section, 3<br>sections @ 30<br>seconds each,<br>proximity sensor<br>to shut off lasers<br>if not in contact,<br>7.5 cm scalp<br>section, automatic<br>turn off | Helmet pauses<br>therapy if<br>subject's head<br>moves outside<br>zone of<br>radiation; after<br>completion of<br>time, unit<br>powers down<br>and audible<br>beep. |

# 1.8 Conclusion

This notification contains all information required by 21 CFR 807.87. Performance testing including electrical, electromagnetic compatibility, biocompatibility, software, and human factors demonstrates REVIAN RED meets the requirements for its intended use and does not raise any new types of safety or effectiveness questions when compared to the predicate device.