iRestore

K151662 · Freedom Laser Therapy, Inc. · OAP · Jan 6, 2016 · Physical Medicine

Device Facts

• Record ID: K151662
• Device Name: iRestore
• Applicant: Freedom Laser Therapy, Inc.
• Product Code: OAP · Physical Medicine
• Decision Date: Jan 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The iRestore 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

iRestore Hair Growth System is a helmet-based device for OTC use to promote hair growth in patients with androgenetic alopecia. Device utilizes 21 red visible light diode lasers and 30 red light super-luminescent diodes (655 nm) to deliver low-level light therapy (LLLT) to the scalp. Helmet design provides hands-free, passive treatment. System includes automatic sensors to pause therapy if head position shifts outside the radiation zone and resumes upon correction; audible beep signals therapy completion. Treatment protocol is 25 minutes, every other day, for 16 weeks. Device is substantially equivalent to the iGrow II system, sharing identical optical, electronic, and mechanical functions, differing only by the omission of integrated earphones. Clinical benefit is derived from established efficacy of LLLT in stimulating hair growth.

Clinical Evidence

No new clinical performance data was produced for this submission. The device relies on clinical data previously established for the predicate iGrow device, which demonstrated safety and efficacy for hair growth in male and female cohorts. Published peer-reviewed studies (Lasers in Surgery and Medicine 2013, 2014) support the 16-week, every-other-day treatment protocol.

Technological Characteristics

Helmet-based LLLT device; 21 red visible light diode lasers and 30 red light super-luminescent diodes (655 nm). Class 3R laser system per IEC standards. Features automatic head-position sensing and audible therapy completion alerts. Standalone operation; no external connectivity. Materials include outer helmet and protective inner liner.

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

• igrow II Hair Growth System (K141567, K140931)

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

January 6, 2016

Freedom Laser Therapy, Inc. % Raymond Blanche Managing Member NST Consulting, LLC 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928

Re: K151662

Trade/Device Name: iRestore Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: November 6, 2015 Received: December 8, 2015

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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 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

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) K151662

Device Name

iRestore Hair Growth System (Model ID-500)

Indications for Use (Describe)

The iRestore 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 Ila- V and for both, Fitzpatrick Classification of Skin Phototypes I to 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

# Freedom Laser Therapy, Inc.

# Submitter's Contact Information

| Name: | Raymond R. Blanche |
|------------|-------------------------------------------------------------------------|
| Address | NST Consulting, LLC<br>641 Shunpike Road, Suite 31<br>Chatham, NJ 07928 |
| Telephone: | [phone] |
| Facsimile: | [phone] |

# Name of Device and Name/Address of Sponsor

| Trade Name: | iRestore Hair Growth System |
|---------------------------------|----------------------------------------------------------------------------------------------------|
| Sponsor Contact<br>Information: | Craig Nabat<br>Freedom Laser Therapy, Inc.<br>7815 Beverly Blvd., 3rd Fl.<br>Los Angeles, CA 90036 |

| 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 II Hair Growth System | Apira Science, Inc. |

# Reference Devices:

None

#### Date Prepared: Revision January 6, 2016

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#### Intended Use / Indications for Use

The iRestore 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 iRestore 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:

No clinical performance data was produced for this submission because the iRestore is an IDENTICAL device in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the igrow. There is one ergonomic design distinction between the two systems. The iRestore is not configured with, audio capability through attached ear phones.

#### Substantial Equivalence

The iRestore device is IDENTICAL to the device known as the igrow Hair Growth System cleared under 510(k) numbers K141567 and K140931. It is as safe and effective as the predicate device.

Both systems, which use red light diode lasers and/or the equivalent, super-luminescent, light emitting diodes 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 the difference in the physical appearance or in the method of delivering the radiant energy of the two systems is of no consequence and does not effect the therapeutic value or the safety profile. The lack of ear phones in the iRestore has no significance in the comparative process between the NEW device and the predicate.

Finally, the clinical data summarized in the 510(k) notice confirms the safety and efficacy of the iRestore Hair Growth System for OTC Use, according to Part 21 CFR 801 Subpart C). For these reasons, the iRestore Hair Growth System satisfies the FDA's substantial equivalence with respect to intended use, technological and design characteristics.

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## Treatment Protocol

The iRestore and the igrow devices possess the same treatment regime of 25 minutes, every other day, on non-consecutive days, for 16 weeks. This treatment regime has been established through clinical testing with the igrow device, in separate male and female cohort clinical trials. The data from these trials was published in a peer review journal. The references are as follows:

- 1. The Growth of Human Scalp Hair Mediated by Visible Red Light Laser and LED Sources in Males. Lasers in Surgery and Medicine 45:487-495 (2013)
- 2. The Growth of Human Scalp Hair in Females Using Visible Red Light Laser and LED Sources. Lasers in Surgery and Medicine 46:601-607 (2014)

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

| iRestore Hair Growth System | igrow Hair Growth System |
|-------------------------------------------------|--------------------------|
| LLLT Device Type | Identical |
| OTC Application | Identical |
| Intended Use - Androgenetic Alopecia | Identical |
| Contain Laser Diodes-21 Class 3R | Identical |
| Contain LEDs, 30 5mm, Thru-The-Hole | Identical |
| Helmet Design | Identical |
| 655 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 | Identical |
| Device Class II | Identical |

With the data presented in the Comparison Chart, the sponsor believes that the this data demonstrates that red light lasers in class IIIa/3R, used in the iRestore Hair Growth System, are substantially equivalent to the igrow Hair Growth system and based on the IDENTICAL technological designs of the two devices, the sponsor requests the FDA to clear the device via the 510(k) notice.