(84 days)
Not Found
No
The summary describes a light therapy device controlled by a mobile app, with no mention of AI, ML, image processing, or data analysis for diagnosis or treatment personalization.
Yes
The device is indicated to treat Androgenetic Alopecia and promote hair growth, which are medical conditions that the device aims to ameliorate or manage.
No
The device is indicated to treat Androgenetic Alopecia and promote hair growth, not to diagnose a condition.
No
The device description explicitly states that the REVIAN RED system is comprised of hardware components including a wearable soft textile Cap, driver electronics, a rechargeable battery, and integrated LED flexible printed circuit board, in addition to the mobile application.
Based on the provided information, the REVIAN RED device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat Androgenetic Alopecia and promote hair growth. This is a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description focuses on its function as a light therapy device applied to the scalp. It does not mention any interaction with biological samples or analysis of bodily fluids or tissues.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, sample collection, or analytical procedures.
Therefore, the REVIAN RED device is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OAP
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 the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use / home-based device
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K162782, K152019, K142573, K122950
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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);
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | ☑ |
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
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.
627 Davis Drive, Suite 400
Morrisville, NC 27560 |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | William A. Knape
Senior Director of Regulatory, Quality and Clinical Affairs
Phone: (919) 757-2033
Email: bknape@photonmd.com |
| 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)
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
4
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.
5
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 | |||
| Growth System | |||||
| (LTD200S) | HairMD | HairMax | |||
| LaserComb 82 | |||||
| (HMLC 82) | LH80 PRO | ||||
| Company | PhotonMD, Inc. | Slinph | |||
| Technologies | Trophy Skin | Lexington | |||
| International | Theradome | ||||
| Product Code | OAP | OAP | OAP | OAP | OAP |
| Rx/OTC | OTC | OTC | OTC | OTC | OTC |
| Intended Use/ | |||||
| Indications for | |||||
| Use | Treat | ||||
| Androgenetic | |||||
| Alopecia and | |||||
| promote hair | |||||
| growth in males | |||||
| who have | |||||
| Norwood- | |||||
| Hamilton | |||||
| Classification IIa | |||||
| to 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 to IV | Promote hair | ||||
| growth in females | |||||
| with | |||||
| Androgenetic | |||||
| Alopecia who | |||||
| have Ludwig- | |||||
| Savin | |||||
| Classification of | |||||
| I-II, in males with | |||||
| Androgenetic | |||||
| Alopecia who | |||||
| have Norwood | |||||
| Hamilton | |||||
| Classifications of | |||||
| IIa-V and for | |||||
| both, Fitzpatrick | |||||
| Classification of | |||||
| Skin Phototypes I |
- IV. | Promote hair
growth in females
with
Androgenetic
Alopecia who
have Ludwig-
Savin
Classification of
I-II, in males with
Androgenetic
Alopecia who
have Norwood
Hamilton
Classifications of
IIa-V and for
both, Fitzpatrick
Classification of
Skin Phototypes I - IV. | Treat
Androgenetic
Alopecia and
promote hair
growth in males
who have
Norwood
Hamilton
Classification
IIa to V patterns
of hair loss and
treat
Androgenetic
Alopecia and,
promote hair
growth in females
who have Ludwig
(Savin) scale I-4,
II-1, II-2 or
frontal, both with
Fitzpatrick skin
types I to IV. | Treat
Androgenetic
Alopecia, to
promote hair
growth in
females with
female pattern
hair loss (FPHL)
on the Ludwig
and Savin Hair
Loss Scale I-II,
Fitzpatrick Skin-
Types I to IV. |
| Wearable
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
source | 119 Red
LEDs | 200 Red Laser
Diodes | 21 Red Laser
Diodes and
30 Red LEDs | 82 Red Laser
Diodes | 80 Red Laser
Diodes |
| Battery | Lithium
Polymer | Lithium
Polymer | Powered by 120V
Wall Plug | Lithium
Polymer | Lithium
Polymer |
Table 1 – Summary of Predicate Devices Compared to REVIAN RED
6
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 | ||||
| 10 mins | Every other day | ||||
| 20-35 mins | Every other day | ||||
| 20 mins | 3 times / week | ||||
| 90 seconds | 2 times / week | ||||
| 20 mins | |||||
| Digital Mobile | |||||
| Controller | Yes | Yes | No | No | No |
| Restrictions on | |||||
| Daily Irradiance | Yes, daily limit | ||||
| for treatments | No | No | No | No | |
| Other Design | |||||
| Characteristics | Cap pauses | ||||
| therapy if subject's | |||||
| head moves | |||||
| outside zone of | |||||
| radiation; after | |||||
| completion of | |||||
| treatment, unit | |||||
| powers down, | |||||
| limits daily | |||||
| treatment to 10 | |||||
| mins, and | |||||
| provides treatment | |||||
| reminders and | |||||
| messages via | |||||
| mobile app | |||||
| controller | Helmet pauses | ||||
| therapy if | |||||
| subject's head | |||||
| moves outside | |||||
| zone of radiation; | |||||
| after completion | |||||
| of time, unit | |||||
| powers down and | |||||
| audible beep. | Helmet pauses | ||||
| therapy if | |||||
| subject's head | |||||
| moves outside | |||||
| zone of radiation; | |||||
| after completion | |||||
| of time, unit | |||||
| powers down and | |||||
| audible beep. | Vibrate so user | ||||
| can move to the | |||||
| next section, 3 | |||||
| sections @ 30 | |||||
| seconds each, | |||||
| proximity sensor | |||||
| to shut off lasers | |||||
| if not in contact, | |||||
| 7.5 cm scalp | |||||
| section, automatic | |||||
| turn off | Helmet pauses | ||||
| therapy if | |||||
| subject's head | |||||
| moves outside | |||||
| zone of | |||||
| radiation; after | |||||
| completion of | |||||
| time, unit | |||||
| powers down | |||||
| and audible | |||||
| 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.