Grivamax Hair Growth System

K171895 · Leana Orders, Inc. · OAP · Aug 22, 2017 · Physical Medicine

Device Facts

• Record ID: K171895
• Device Name: Grivamax Hair Growth System
• Applicant: Leana Orders, Inc.
• Product Code: OAP · Physical Medicine
• Decision Date: Aug 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Grivamax Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Device Story

Grivamax Hair Growth System is a Low-Level Laser Therapy (LLLT) device designed for home use to promote hair growth. It consists of a helmet containing 272 diode lasers (650+/-5 nm) powered by a lithium-ion battery. The device is operated by the patient in a hands-free manner. The user wears the helmet for 30-minute sessions, every other day, for an initial 16-week period. The device provides full coverage of the upper third of the scalp. It is an over-the-counter (OTC) device intended for individuals with specific androgenetic alopecia classifications. The device is identical to the predicate Illumiflow Laser Cap, sharing the same optical, electronic, and mechanical design. No clinical performance data was generated for this submission; equivalence is based on the identical nature of the device to the predicate.

Clinical Evidence

No clinical performance data was produced for this submission. The device is identical to the predicate (K162071). An OTC human factors/usability study was conducted with 40 subjects to evaluate self-selection, assembly, and comprehension of hazards/maintenance. The study achieved a 90% pass rate, exceeding the 80% success threshold.

Technological Characteristics

LLLT device; 272 diode lasers (650+/-5 nm); Class 3R laser system per IEC 60825-1; lithium-ion battery powered; helmet form factor with protective inner liner; embedded controller chip. Conforms to IEC 60601-1-2 (EMC) and IEC 60825-1 (Laser Safety).

Indications for Use

Indicated for females with androgenetic alopecia (Ludwig-Savin I-II) and males with androgenetic alopecia (Norwood-Hamilton IIa-V), 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

• Illumiflow Laser Cap (K162071)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 22, 2017

Leana Orders, Inc. % Raymond Blanche Managing Member NST Consulting, LLC 641 Shunpike Road Chatham, New Jersey 07928

Re: K171895

Trade/Device Name: Grivamax Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: June 1, 2017 Received: June 26, 2017

Dear Raymond 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 Actinclude 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely. Jennifer R. Stevenson -S

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

K171895

510(k) Number (if known)

Device Name GrivaMax Hair Growth System

Indications for Use (Describe)

The GrivaMax Hair Growth System 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 IIa-V and for both, Fitzpatrick Classification of Skin Phototypes of I-IV.

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

### Leana Orders, Inc.

# Submitter's Contact Information

| Name: | Raymond R. Blanche |
|------------|--------------------------------------------------------------------------|
| Address | NST Consulting, LLC<br>641 Shunpike Road, Suite 311<br>Chatham, NJ 07928 |
| Telephone: | (973-539-7444 |
| Facsimile: | [phone] |

### Name of Device and Name/Address of Sponsor

| Trade Name: | Grivamax Hair Growth System |
|---------------------------------|-----------------------------------------------------------------------------------------|
| Sponsor Contact<br>Information: | Leonid Krits<br>Leana Orders, Inc.<br>431 Travis Avenue<br>Staten Island, NY 10314-6150 |
| Telephone: | 718-415-1901 |
| 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 |
|----------------------|-----------------------------------|
| Illumiflow Laser Cap | Cosmo Far East Technology Limited |

### Reference Devices:

None

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Date Prepared:

August 17, 2017 Revised

#### Intended Use / Indications for Use

The Grivamax Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II, males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

### Technological Characteristics

The Grivamax Hair Growth System consists of 272 diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The Grivamax Hair Growth System is powered by a lithium-ion battery pack that contains an embedded controller chip.

#### Performance Data:

No clinical performance data was produced for this submission because the Grivamax Hair Growth System is the same device as the predicate, the Illumiflow Laser Cap, cleared under K162071. Both the Grivamax Hair Growth System and Illumiflow Laser Cap are the IDENTICAL same device offered for PRIVATE LABEL by the manufacturer, Cosmo Far East Technology Limited. They are the same device in optical, electronic, mechanical function and aesthetic appearance, as well as the same recommended clinical treatment regime.

#### Substantial Equivalence

Both the Grivamax Hair Growth System and Illumiflow Laser Cap which use red light diode lasers are classified as class IIIa/3R laser systems by the IEC standard for allowable emission levels, which is a recognized standard by the FDA as well, and the adverse event profile is the same. The sponsor believes that there is no difference in the physical appearance or in the method of delivering the radiant energy of the two systems and therefore, there are no variations in the therapeutic value or safety profile.

Finally, the summarized data contained in the Illumiflow Laser Cap in the 510(k) notice confirms the safety and efficacy of the device and accordingly, of the proposed Grivamax Hair Growth System for Over-the-Counter Use per Part 21 CFR 801 Subpart C. For these reasons, the Grivamax Hair Growth System overwhelmingly satisfies the FDA's substantial equivalence with respect to intended use, technological and design characteristics.

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### Treatment Protocol

The Grivamax Hair Growth System and the Illumiflow Laser Cap igrow devices possess the same treatment regime of 30 minutes, every other day, on non-consecutive days, for the initial treatment regime of 16 weeks.

The following Comparison Chart in support of substantial equivalence is provided:

| Grivamax Hair Growth System | Illumiflow Laser Cap |
|------------------------------------------------------------------|----------------------|
| LLLT Device Type | Identical |
| OTC Application | Identical |
| Intended Use - Androgenetic Alopecia | Identical |
| Contain Laser Diodes-272 Class 3R | Identical |
| Helmet Design | Identical |
| 650+/-5 NMS. | Identical |
| Marketing Clearance -Females & Males, OTC | Identical |
| Passive Use-Hands Free | Identical |
| OAP Classification | Identical |
| Classification Name -Infrared Lamp | Identical |
| Common Usage Name - Lamp, Non-Heating | Identical |
| General & Plastic Surgery Committee | Identical |
| Skin Phototypes - I- IV | Identical |
| Hamilton-Norwood IIa-V Hair Loss Classification | Identical |
| Ludwig-Savin I - II Hair Loss Classification | Identical |
| Efficacy Rates - High Compared to Placebo | Identical |
| Treatment- 16 weeks, every other day, for 30 minutes per session | Identical |
| Device Class II | Identical |

With the data presented in the Comparison Chart, the sponsor believes that this data demonstrates that the two devices are identical and equivalent. PRIVATE LABEL devices from the same manufacturer and therefore are identical because the manufacturer ONLY produces one device.

Based on this comparison and determination, the sponsor requests the FDA to clear the device via the 510(k) notice.

### Over - The - Counter Testing Program

To test volunteer subjects for the suitability of the Grivamax Hair Growth System, 40 subjects were asked twenty-six questions (see questionnaires) after being provided a standard retail package and a full owner's manual. The test subjects was given as long as they required to read and understand the product packaging and manual. No assistance was provided to them and they were not permitted to ask any questions of the interviewer. The interviewer then conducted the interview and filled in the responses

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from the subjects. The subjects were required to answer all questions correctly to be counted as PASS for the correct Self Selection or, to have made the correct decision to purchase the product or not; to assemble and use the product correctly and comprehend the hazards and maintenance procedures for the device. These decisions would be based upon their understanding of the Intended Use of the product and the manual.

If the questions were answered correctly, they were given a P for PASS. If any questions were answered incorrectly, they were given an F for FAIL. The number of subjects required to answer all questions correctly is 32 out of 40, for an 80% success rate.

The results of the Over-the-Counter testing demonstrate that the Grivamax Hair Growth System complies with the requirements the FDA determined to be applicable. The test revealed an overall 90% pass rate for the subject group of 40 male and female participants. The testing further demonstrates that age, education, socioeconomic group, race or medical hair loss status are not variants that prevent proper self-selection, usability and comprehension of hazards and maintenance procedures for the average consumer to successfully navigate the purchasing and use process of the Grivamax Hair Growth System.

Based on this data, the sponsor believes that the Grivamax Hair Growth System for male and female users should be granted the OTC intended use as requested.

### Electrical Safety and Electromagnetic Compatibility Testing Performance

The Grivamax Hair Growth System was evaluated for conformance to recognized international standards. The following is a list of these evaluations and tests that were found to be in conformance:

- 1. IEC 60825-1 Edition 2.0 2007-03 Safety of Laser Products Part 1: Equipment Classification and Requirements.
- 2. IEC 60601-1-2 Edition 3.0 2007-03 Medical Electrical Equipment Part 1-2 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Part 1: Requirements and Tests.