ID-510 iRestore Elite

K222081 · Freedom Laser Therapy, Inc. · OAP · Oct 13, 2022 · Physical Medicine

Device Facts

• Record ID: K222081
• Device Name: ID-510 iRestore Elite
• Applicant: Freedom Laser Therapy, Inc.
• Product Code: OAP · Physical Medicine
• Decision Date: Oct 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ID-510 iRestore Elite is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

Device Story

Low-level laser/light therapy (LLLT) helmet for home use; treats androgenetic alopecia. Device inputs: line voltage (100/240V). Device transforms electrical energy into fixed-level light emission via 300 laser diodes (680nm) and 200 super luminescent diodes (625nm, 655nm). Delivers 2500mW total output per 12-minute session. Operator (patient) wears helmet; system operation is fixed and cannot be altered. Output: red light exposure to scalp. Benefit: promotes hair growth. Construction: ABS plastic helmet with silicone pad fixation ring.

Clinical Evidence

Bench testing only. Testing included cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), electrical safety (ANSI AAMI 60601-1), EMC (IEC 60601-1-2), software V&V, lifetime testing (5 years), and transportation testing (ASTM D4169).

Technological Characteristics

ABS plastic helmet with silicone fixation ring. Light source: 300 laser diodes (680±10nm) and 200 super luminescent diodes (625±10nm, 655±10nm). Laser Class 3R. Power: 2500mW total. Line voltage 100/240V. Standards: ISO 10993-5/10, ANSI AAMI 60601-1, IEC 60601-1-2, ASTM D4169.

Indications for Use

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

• ID-500 iRestore Hair Growth System (K213094)

Reference Devices

• iRestore Professional 282 (K183417)
• REVIAN RED (K173729)
• Theradome LH40 (K180460)
• Capillus 112 (K192012)
• Capillus 244 (K192012)

Submission Summary (Full Text)

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October 13, 2022

Freedom Laser Therapy, Inc. % Sharon Chen Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K222081

Trade/Device Name: ID-510 iRestore Elite Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: July 12, 2022 Received: July 15, 2022

Dear Sharon Chen:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jianting Wang Acting Assistant 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

#### K222081

Device Name

# ID-510 iRestore Elite

Indications for Use (Describe)

The ID-510 iRestore Elite is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of Ila-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 5. 510(k) Summary K222081

### 5.1 Submission Sponsor

Freedom Laser Therapy Inc. 16782 Von Karman Ave, Unit 15 Irvine, CA, 92606 USA Contact: Wei-Chih (Kevin) Chen Title: President

## 5.2 Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] Email: LST.AUS.ProjectManagement(@ul.com Contact: Sharon Chen Title: Regulatory Consultant

#### 5.3 Date Prepared

July 12, 2022

#### 5.4 Device Identification

| Trade Name: | ID-510 iRestore Elite |
|----------------------|-----------------------|
| Classification Name: | Physical Medicine |
| Regulation Name: | Infrared Lamp |
| Regulation Number: | 21 CFR 890.5500 |
| Product Code: | OAP |
| Class: | Class II |

#### 5.5 Legally Marketed Predicate Device

| Trade Name: | ID-500 iRestore Hair Growth System |
|----------------------|------------------------------------|
| 510(k) Number: | K213094 |
| Classification Name: | Physical Medicine |
| Regulation Name: | Infrared Lamp |
| Regulation Number: | 21 CFR 890.5500 |
| Product Code: | OAP |
| Class: | Class II |

#### 5.6 Reference Devices

iRestore Professional 282 (K183417), manufactured by Remax Medi-Tech (Shenzhen) Corporation

REVIAN RED (K173729), manufactured by PhotonMD, Inc.

Theradome LH40 (K180460), manufactured by Theradome, Inc.

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## 5.7 Indications for Use Statement

The ID-510 iRestore Elite is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

### 5.8 Device Description

The ID-510 iRestore Elite is a low-level laser/light system operating at 680 ± 10, 655 ± 10, and 625± 10 nanometers. The physical configuration is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The device helmet is constructed of an ABS type plastic. The system operates on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any heads of non-toxic silicone pads. The helmet contains 300 units of five-millwatt-diode lasers and 200 units of fivemilliwatt, super luminescent diodes, that emit red light. This system delivers fixed laser emission levels, measured to be 2500 total millwatts per 12 minute treatment session, which cannot be altered by the operator.

#### 5.9 Substantial Equivalence Discussion

The following table compares the ID-510 iRestore Elite to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

| Attribute | ID-510<br>iRestore Elite | ID-500<br>iRestore Hair<br>Growth<br>System | iRestore<br>Professional<br>282 | REVIAN<br>RED | Theradome<br>LH40 | Capillus 112,<br>Capillus 244 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Category | Subject<br>Device | Predicate<br>Device | Reference<br>Device | Reference<br>Device | Reference Device | Reference<br>Device |
| 510(k)<br>Number | Not applicable | K213094 | K183417 | K173729 | K180460 | K192012 |
| Manufacturer | Remax Medi-<br>Tech<br>(Shenzhen)<br>Corporation | Remax Medi-<br>Tech<br>(Shenzhen)<br>Corporation | Remax Medi-<br>Tech<br>(Shenzhen)<br>Corporation | PhotonMD,<br>Inc. | Theradome, Inc. | Capillus |
| Product Code | OAP | OAP | OAP | OAP | OAP | OAP |
| Regulation<br>Number | 21 CFR<br>890.5500 | 21 CFR<br>890.5500 | 21 CFR<br>890.5500 | 21 CFR<br>890.5500 | 21 CFR 890.5500 | 21 CFR<br>890.5500 |
| Indications<br>for Use | The ID-510<br>iRestore Elite<br>is indicated to<br>promote hair<br>growth in<br>males who<br>have<br>Norwood-<br>Hamilton<br>Classifications | The predicate<br>Is indicated to<br>treat<br>androgenetic<br>alopecia in<br>men<br>It is<br>designed to<br>promote | The iRestore<br>Professional<br>282<br>is indicated<br>for promote<br>hair and<br>growth in<br>females with<br>to androgenetic<br>hair alopecia | REVIAN RED<br>is indicated to<br>treat<br>Androgenetic<br>hair Alopecia<br>in promote<br>growth<br>males<br>who have<br>Norwood-Hamilton | The Theradome<br>LH40<br>(Theragrow) is an<br>over the counter<br>and (OTC)<br>hair therapeutic<br>in device<br>to treat<br>Androgenetic<br>Alopecia | The CapillusX<br>and CapillusX+<br>laser domes are<br>intended to treat<br>Androgenetic<br>Alopecia and<br>promotion of<br>hair growth in<br>males who have<br>and Norwood |
| | of IIa-V, and males<br>in females have<br>with androgenetic<br>alopecia who<br>have Ludwig-<br>Savin<br>Classifications<br>of I-II, and in<br>both,<br>Fitzpatrick<br>Classification<br>of<br>Phototypes<br>to IV. | | who Savin<br>Classifications<br>of I-II, males<br>who have loss and<br>Norwood-<br>Hamilton<br>Classifications<br>of IIa to V and<br>in Ludwig-<br>Savin<br>Classifications<br>of I to II. All of<br>Skin users should<br>I also<br>Skin Types I<br>to IV. | Classifications<br>promote<br>treat<br>Androgenetic<br>Alopecia<br>for both, growth<br>Fitzpatrick<br>Classification<br>Skin Savin Scale I-1<br>I to I-4, II-1, II-2<br>or frontal<br>patterns of hair | | hair Hamilton<br>Classifications<br>of IIa - V growth in<br>have of IIA to V<br>loss and treating<br>Classifications of<br>and IIa to V patterns<br>hair of hair loss and to<br>in treat<br>females who<br>and have<br>hair (Savin) Scale 1-<br>in 4. II-1, II-2, or<br>who frontal; both<br>Skin Types I to |
| OTC or Rx Only | OTC | OTC | OTC | OTC | OTC | OTC |
| Wavelength<br>of LED | 625 ± 10 nm<br>and 655 ± 10 nm | 655 ± 10 nm | 655 ± 10 nm | 620 – 660 nm | No LED | No LED |
| Wavelength<br>of Laser | 680 ± 10 nm | 655 ± 10 nm | 655 ± 10 nm | No laser | 620 - 660 nm | 678 ± 7 nm |
| Laser Power<br>for<br>Classification | Laser Class 3R | Laser Class 3R | Laser Class 3R | Not applicable | Laser Class 3R | Laser Class 3R |
| Time and<br>Frequency of<br>Treatment | 12 minutes per<br>treatment, to be<br>used daily. | 25 minutes per<br>treatment, to be<br>used every day. | 25 minutes per<br>treatment, to be<br>used other every<br>day. | 10 minutes per<br>treatment, to be<br>used daily. | 20 minutes per<br>treatment, to be<br>used four times<br>per week. | Six minutes per<br>treatment, to be<br>used daily. |

Table 5.1: Comparison of Characteristics

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#### 5.10 Non-Clinical Performance Data

To demonstrate safety and effectiveness of ID-510 iRestore Elite and to show substantial equivalence to the predicate device, Remax Medi-Tech (Shenzhen) Corporation completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The ID-510 iRestore Elite passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:

- · Cytotoxicity testing per ISO 10993-5 Passed
- · Sensitization testing per ISO 10993-10 Passed
- · Electrical safety testing per ANSI AMMI 60601-1 Passed
- · Electromagnetic Disturbance (EMC) testing per IEC 60601-1-2 Passed
- · Software verification and validation per FDA Guidance Compliant
- · Lifetime Testing Supports lifetime of five years

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- · Transportation Testing per ASTM D4169 Demonstrates package integrity maintained
#### 5.11 Statement of Substantial Equivalence

The ID-510 iRestore Elite has the same indications for use as the ID-500 iRestore Hair Growth System. Any minor differences in the technological characteristics of the subject device when compared to the predicate device have been successfully evaluated through appropriate safety and performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, ID-510 iRestore Elite has been determined to be substantially equivalent to ID-500 iRestore Hair Growth System.