(118 days)
No
The device description focuses on hardware components (lasers, LEDs) and basic safety features (interlock, audible tones). There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is indicated to "promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V". This addresses a medical condition (androgenetic alopecia) by promoting hair growth, which is a therapeutic effect.
No
The device is indicated to promote hair growth and its description focuses on light emission for therapy, not on diagnosing medical conditions.
No
The device description explicitly states it consists of physical components like lasers, LEDs, a helmet, and a power source, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided information, the HairMD device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- HairMD Function: The HairMD device is a light-based therapy system that applies light directly to the scalp to stimulate hair growth. It does not involve testing samples taken from the body.
- Intended Use: The intended use clearly states it's for promoting hair growth in individuals with androgenetic alopecia, which is a direct treatment application, not a diagnostic test.
- Device Description: The description details a helmet with lasers and LEDs, designed for external application to the head.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activities associated with in vitro diagnostics.
Therefore, the HairMD is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HairMD is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V and for both, Fitzpatrick Classification of Skin Phototypes of I-IV.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
The HairMD consists of 21 red, visible-light, continuous wave diode lasers operating at 650 nanometers and 30 super luminescent light emitting diodes (LEDs), operating at 650 nanometers that are configured within a protective inner liner and outer helmet. The HairMD is physically similar to the iGrow Hair Growth System, except that it does not contain earphones or inner liner spacers. The use of these specific number of diode lasers and LEDs, provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by line voltage, operating at 110/220 volts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper 1/3 of the head
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical trial data for the HairMD was submitted for this 510(k). The device was tested for conformance with IEC 60601-1-11 (edition 3.0), and IEC 60825-1 (edition 1.2). The testing results demonstrate that the HairMD device performed safely and effectively and that the device does not raise new types of questions regarding effectiveness or safety when compared to the predicate device.
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.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Trophy Skin Incorporated % Mr. Raymond R. Blanche NST Consulting, LLC 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928
November 16, 2015
Re: K152019
Trade/Device Name: HairMD Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: September 24, 2015 Received: October 22, 2015
Dear Mr. Blanche:
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 (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
For 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) K152019
Device Name HairMD
Indications for Use (Describe)
The HairMD is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila-V and for both, Fitzpatrick Classification of Skin Phototypes of I-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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510(k) Summary
Trophy Skin, Inc.
Submitter's Contact Information
| Name: | Raymond R. Blanche |
|---|---|
| Address | NST Consulting, LLC |
| 641 Shunpike Road, Suite 311 | |
| Chatham, NJ 07928 | |
| Telephone: | (973) 539-7444 |
| Facsimile: | (973) 539-7445 |
Name of Device and Name/Address of Sponsor
| Trade Name: | HairMD |
|---|---|
| Sponsor Contact Information: | Imran Karim |
| Trophy Skin, Inc. | |
| 4372 Kenmare Trail | |
| Frisco, Texas 75034 | |
| T. 469-233-1768 | |
| Common or Usual Name: | Lamp, non-heating, for promotio |
| Common or Usual Name: | Lamp, non-heating, for promotion of hair growth |
|---|---|
| Classification Name: | Infrared lamp per 21 CFR 890.5500 |
| Classification Code: | OAP (Laser, comb, hair) |
Predicate Devices:
Device Trade Name
Manufacturer
iGrow Hair Growth System-K140931 iGrow Hair Growth System-K141567
Apira Science, Inc.
Apira Science, Inc.
Reference Devices:
Hairmax Lasercomb - K142573
Lexington International
Date Prepared:
Revised, November 12, 2015
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Intended Use / Indications for Use
The HairMD is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Technological Characteristics
The HairMD consists of 21 red, visible-light, continuous wave diode lasers operating at 650 nanometers and 30 super luminescent light emitting diodes (LEDs), operating at 650 nanometers that are configured within a protective inner liner and outer helmet. The HairMD is physically similar to the iGrow Hair Growth System, except that it does not contain earphones or inner liner spacers. The use of these specific number of diode lasers and LEDs, provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by line voltage, operating at 110/220 volts.
Performance Data:
No clinical trial data for the HairMD was submitted for this 510(k). The device was tested for conformance with IEC 60601-1-11 (edition 3.0), and IEC 60825-1 (edition 1.2). The testing results demonstrate that the HairMD device performed safely and effectively and that the device does not raise new types of questions regarding effectiveness or safety when compared to the predicate device.
5
Substantial Equivalence
The HairMD utilizes the same technological characteristics as the predicate device. The HairMD uses the same pulsing characteristics for its laser diodes and LEDs as the K140931 and K141567 (iGrow Hair Growth System)) device, and provides similar energy and irradiance output to the treatment area as this predicate.
The HairMD is designed to provide low-level-laser therapy. Both the predicate device and the proposed device use red light diode lasers and LEDs operating at the same wavelength of light, 650 nanometers. The sponsor believes that the differences between the subject device of this 510(k) compared with the predicate device, does not substantially affect the therapeutic value or the safety profile. There are differences in the physical appearance of the HairMD compared to the iGrow Hair Growth System. These differences are not significant and do not affect the safety or efficacy profile of the proposed device.
Conclusion
The HairMD utilizes the same technological characteristics as the predicate device listed above, and is to be used for the same intended use. The sponsor believes that there are no new types of safety and effectiveness questions for the HairMD when compared with the predicate device, and therefore that the device should be considered substantially equivalent to the predicate devices.