IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM

K141567 · Apira Science, Inc. · OAP · Aug 21, 2014 · Physical Medicine

Device Facts

• Record ID: K141567
• Device Name: IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM
• Applicant: Apira Science, Inc.
• Product Code: OAP · Physical Medicine
• Decision Date: Aug 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

Device Story

iGrow-II Hair Growth System is a helmet-based device for home use by patients to promote hair growth. It utilizes 21 red visible light diode lasers and 30 red light super-luminescent diodes to provide coverage to the upper third of the head. The device features an automatic pause/resume function triggered by head position sensors to ensure therapy occurs within the radiation zone. Upon completion of the therapy cycle, the device emits an audible beep pattern to signal the user. The system is designed for over-the-counter (OTC) use, allowing patients to operate the device without physician intervention. The device benefits patients by providing a non-invasive, self-administered treatment for androgenetic alopecia.

Clinical Evidence

No clinical efficacy data provided. Evidence is restricted to a self-selection and usability study involving 30 male subjects. The study assessed comprehension of user instructions, warnings, and precautions to support OTC classification. The device achieved an 83.33% pass rate, exceeding the 80% requirement set by FDA guidance.

Technological Characteristics

Helmet-based system containing 21 red visible light diode lasers and 30 red light super-luminescent diodes. Features head position sensors for automatic therapy pause/resume functionality and audible signaling for cycle completion. Designed for OTC use.

Indications for Use

Indicated for males with androgenetic alopecia, Hamilton-Norwood Classifications IIa-V, and Fitzpatrick Skin Phototypes I-IV.

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

• Hairmax Lasercomb

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 21, 2014

Apira Science, Inc. % NST Consulting, LLC Raymond R. Blanche 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928

Re: K141567

Trade/Device Name: igrow-II Hair Growth System Regulation Number: 21 CFR 890.5500 Regulatory Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: July 25, 2014 Received: July 31, 2014

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# David Krause -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

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### Indications for Use

510(k) Number (if known) K141567

Device Name igrow-II Hair Growth System

The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and 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)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

## Apira Science, Inc.

## Submitter's Contact Information

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

## Name of Device and Name/Address of Sponsor

| Trade Name: | igrow-II Hair Growth System |
|---------------------------------|-------------------------------------------------------------------------------------------|
| Sponsor Contact<br>Information: | Morgan Pepitone<br>Apira Science, Inc.<br>2601 Main Street, Suite 530<br>Irvine, CA 92614 |
| 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 |
|-------------------|------------------------------|
| Hairmax Lasercomb | Lexington International, LLC |

# Date Prepared:

February 10, 2014

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#### Intended Use / Indications for Use:

The igrow-II Hair Growth System is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

#### Technological Characteristics:

The Igrow-II Hair Growth System consists of 21 red visible light, diode lasers and 30 red light super-luminescent diodes configured within an outer helmet and protective inner. The use of diode lasers and non-laser 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. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

#### Performance Data:

The data presented in this submission is restricted to Self -Selection and Usability to include comprehension of user instructions and warnings and precautions. The results of a Presubmission meeting provided the objectives that must be fulfilled for the igrow to be classified as an Over-the-Counter device. This guidance stipulated that a minimum of an 80% success rate must be achieved for the Intended Use of OTC to be granted. The testing was administered to 30 male subjects of any age, educational background, race, disease status present or pre-education about the testing to be performed. This was designed to provide for the broadest test criteria without any bias being imposed, thereby assessing the real world capability of the average male, "retail customer" who might wish to purchase a device without the benefit of a physician or other qualified health care provider to provide counsel as is the case with prescription devices.

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The igrow testing demonstrated a pass rate of 83.33%, satisfying the FDA's requirements for an Over-the-Counter Intended Use.

## Substantial Equivalence:

The requirements set for substantial equivalence in the traditional sense, do not have applicability in this process because the threshold for success has been set by the formal guidance provided to the sponsor by through the FDA's Presubmission Meeting process. However, The Hairmax Lasercomb has been cleared with the Intended Use of Over-the-Counter and therefore, the igrow Hair Growth System is substantially equivalent to the Hairmax Lasercomb by meeting or exceeding the minimum requirements set by the FDA's process of Presubmission Meeting guidance.

### Revision.01. July 25, 2014