iRestore Professional 282
Device Facts
| Record ID | K183417 |
|---|---|
| Device Name | iRestore Professional 282 |
| Applicant | Freedom Laser Therapy, Inc. |
| Product Code | OAP · Physical Medicine |
| Decision Date | May 17, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The iRestore Professional 282 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 Professional 282 is a helmet-based, hands-free, low-level laser therapy (LLLT) device for home use. It utilizes 82 red diode lasers and 200 red light super-luminescent diodes (650 nm) to provide light therapy to the scalp. The device operates on a 25-minute treatment cycle, performed every other day. It features an integrated sensor system that automatically pauses therapy if the user's head moves outside the radiation zone and resumes when the correct position is re-established; an audible beep signals the end of the therapy cycle. The device is intended for consumer self-selection and operation. By delivering light energy to the scalp, it aims to promote hair growth in patients with androgenetic alopecia. It is designed for OTC purchase and use.
Clinical Evidence
No clinical performance data was produced for this submission. The device relies on its similarity in optical, electronic, and mechanical function to the predicate device (K151662). Bench testing was conducted to demonstrate compliance with international standards, including IEC 60825-1 (laser safety), IEC 60601-1 (basic safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home use), and ISO 10993-1 (biocompatibility). An OTC usability study with 30 subjects demonstrated a 90% pass rate for self-selection, assembly, and comprehension of hazards and maintenance.
Technological Characteristics
Helmet-based LLLT device; 82 red diode lasers (650 nm +/- 10nm) and 200 red super-luminescent diodes. Class 3R laser system. Features automatic head-position sensing and audible cycle completion alerts. Complies with IEC 60825-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62304, ISO 14971, and ISO 10993-1/10. Powered for home use.
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
- iRestore Hair Growth System (K151662)
Reference Devices
- HairMax Lasercap (K180885)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows 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.
Freedom Laser Therapy, Inc. Mr. Raymond Blanche Consultant NST Consultants, Inc. 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928
May 17, 2019
Re: K183417
Trade/Device Name: iRestore Professional 282 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 21, 2018 Received: March 20, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 Stevenson, For Acting Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K183417
Device Name iRestore Professional 282
Indications for Use (Describe)
The iRestore Professional 282 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.
| 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 Consultants, Inc<br>641 Shunpike Road, Suite 311<br>Chatham, NJ 07928 |
| Telephone: | (973) 539-7444 |
| Facsimile: | (973) 539-7445 |
| Name of Device and Name/Address of Sponsor | |
| Trade Name: | iRestore Professional 282 |
| Sponsor Contact<br>Information: | Craig Nabat<br>Freedom Laser Therapy, Inc.<br>16782 Von Karman Avenue, Unit #15<br>Irvine, CA 92606<br>T. 714-669-9888<br>F. 714-730-9989 |
| 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 |
|----------------------------------------|-----------------------------|
| iRestore Hair Growth System<br>K151662 | Remax Medi-Tech Corporation |
| Reference Devices: | |
| HairMax Lasercap<br>K180885 | Lexington International |
| Date Prepared: | May 15, 2019 |
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#### Intended Use / Indications for Use
The iRestore Professional 282 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 Professional 282 consists of 82 red visible light, diode lasers and 200 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 Professional 282 is a device similar in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the iRestore Hair Growth System K151662. There is one design distinction between the two systems. The iRestore Professional 282 contains an increased number of laser didoes and LEDs over the iRestore Hair Growth System.
The iRestore Professional 282 was tested to internationally recognized standards, consistent with the current recommendations adopted by the FDA.
- 1. IEC 60825-1 Edition 2.0 2007 03 Laser Safety & Classification
- 2. IEC 60601-1:2005 (currently called AAMI/ANSI standard) Basic Safety and Essential Performance
- 3. IEC 60601-1-2 Edition 1.0. 2010 -04 EMC. This replaces Edition 3.0 2007 03
- 4. IEC 60601-1-11 Edition 1.0 2014 06 Home Use. This replaces Edition 2010 04
- 5. IEC 62304 Edition 1.1 2015 06 Software and Life Cycle Processes
- 6. ISO 14971 Second edition 2007 03 01 Application of Risk Management to Medical Devices
- 7. ISO 10993-1 2009 (R) 2013 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing within a Risk Management Process. ISO 10993-10:2010/(R) 2014 -Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
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### Over - The - Counter Testing Program
To test volunteer subjects for the suitability of the iRestore Professional 282, 30 subjects were asked twenty-six questions, 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 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 24 of 30 for a 80% success rate.
The results of the Over-the-Counter testing demonstrate that the iRestore Professional 282 comply with the requirements the FDA determined to be applicable. The test revealed an overall 90% pass rate for the subject group of 30 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 iRestore Professional 282.
Based on this data, the sponsor believes that the iRestore Professional 282 for male and female users has met the requirements for OTC sale.
### Substantial Equivalence
The iRestore Professional 282 device is similar to the device known as the iRestore Hair Growth System. FDA Cleared under K151662. 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 essentially the same and does not alter the safety profile. Finally, the comparative data summarized in the 510(k) notice confirms the safety and efficacy of the iRestore Professional 282 for OTC Use, according to Part 21 CFR 801 Subpart C. For these reasons, the iRestore Professional 282 satisfies the FDA's substantial equivalence with respect to intended use, technological and design characteristics.
### Treatment Protocol
The iRestore Professional 282 and the iRestore Hair Growth System possess the same treatment regime of 25 minutes, every other day, on non-consecutive days, for 16 weeks.
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The following Comparison Chart in support of substantial equivalence is provided:
| iRestore Professional 282 (Proposed) | iRestore Hair Growth System (K151662) |
|-----------------------------------------------------------|-------------------------------------------------|
| LLLT Device Type | LLLT Device Type |
| OTC Application | OTC Application |
| Intended Use - Androgenetic Alopecia | Intended Use - Androgenetic Alopecia |
| Contain Laser Diodes-82 Class 3R | Contain Laser Diodes-21 Class 3R |
| Contain LEDs, 200, SMD | Contain LEDs, 30, 5mm, Thru-the-Hole |
| Helmet Design | Helmet Design |
| 650 nm +/- 10nm. | 650 nm +/- 10nm |
| Marketing Clearance -Females & Males, OTC | Marketing Clearance -Females & Males, OTC |
| Passive Use-Hands Free | Passive Use-Hands Free |
| OAP Classification | OAP Classification |
| Classification Name -Infrared Lamp | Classification Name -Infrared Lamp |
| General & Plastic Surgery Committee | General & Plastic Surgery Committee |
| Skin Phototypes - I- IV | Skin Phototypes - I- IV |
| Hamilton-Norwood IIa-V Hair Loss Classification | Hamilton-Norwood IIa-V Hair Loss Classification |
| Ludwig-Savin I – II Hair Loss Classification | Ludwig-Savin I – II Hair Loss Classification |
| Treatment- 16 weeks, for 25 minute treatment times, three | Treatment- 16 weeks, for 25 minute treatment |
| times a week on alternate days | times, three times a week on alternate days |
| Device Class II | Device Class II |
### Conclusion
With the data presented in the Comparison Chart, the sponsor believes that this demonstrates the iRestore Professional 282, is substantially equivalent to the iRestore Hair Growth System based upon the equivalent technological designs of the compared devices, the sponsor requests the FDA to clear the device via the 510(k) notice.
