(89 days)
No
The device description and performance studies focus on low-level laser/light technology and standard safety/performance testing, with no mention of AI or ML.
Yes
The device is indicated to treat androgenetic alopecia and promote hair growth, which are medical treatments.
No
The device is indicated to treat androgenetic alopecia and promote hair growth, which are therapeutic functions, not diagnostic ones. It does not identify, assess, or monitor a disease.
No
The device description explicitly details a physical helmet containing lasers and LEDs, operating on line voltage. While software verification and validation are mentioned, the core of the device is hardware-based.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ID-500 iRestore Hair Growth System is a low-level laser/light system that is applied externally to the head to stimulate hair growth. It does not analyze any biological samples.
- Intended Use: The intended use is to treat androgenetic alopecia and promote hair growth, which is a therapeutic application, not a diagnostic one.
Therefore, based on the provided information, the ID-500 iRestore Hair Growth System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ID-500 iRestore Hair Growth System: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV.
Product codes
OAP
Device Description
The ID-500 iRestore Hair Growth System are two low-level laser/light systems operating at different wavelengths. The ID-500 iRestore Hair Growth System consists of laser and LED operating at 655 ± 10 nanometers. The physical configuration of the device is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The systems operate on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any head shape by means of non-toxic silicone pad. The helmet contains 5-millwatt-diode lasers and 5-milliwatt, super luminescent diodes, that emit red light.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate safety and effectiveness of the ID-500 iRestore Hair Growth System and to show substantial equivalence to the predicate device. The ID-500 iRestore Hair Growth System a completed the following nonclinical tests. Results confirm that the design inputs and performance specifications for the device are met. The subject devices passed the testing in accordance with national standards standards shown below, supporting their safety and effectiveness, and their substantial equivalence to the predicate device:
- Cytotoxicity testing per ISO 10993-5 Passed.
- Irritation testing per ISO 10993-10 Passed.
- Sensitization testing per ISO 10993-10 Passed.
- Electrical safety testing per ANSI AAMI ES60601-1:2005((R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 - Passed.
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 Passed.
- Home used environment testing per IEC 60601-1-11 Passed.
- Laser safety testing per IEC 60825-1 Passed.
- Software verification and validation per FDA Guidance Compliant.
- Product life time testing Supports life time of 5 years.
- Transportation testing per ASTM D4169-16 Demonstrates package integrity maintained.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5500 Infrared lamp.
(a)
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.(b)
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.
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Image /page/0/Picture/0 description: The image contains 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.
December 22, 2021
Freedom Laser Therapy, Inc. % Sharon Chen Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K213094
Trade/Device Name: ID-500 iRestore Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: September 23, 2021 Received: September 24, 2021
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.
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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya 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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Indications for Use
510(k) Number (if known) K213094
Device Name ID-500 iRestore Hair Growth System
Indications for Use (Describe)
ID-500 iRestore Hair Growth System: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to 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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5. 510(k) Summary
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
5.1 Submitter Information
| Company: | Wei-Chih (Kevin) Chen
President
Freedom Laser Therapy, Inc.
16782 Von Karman Ave, Unit 15
Irvine, CA 92606 USA
Telephone: (714) 669-9888
Fax: 949-748-8639
kevin@freedomlasertherapy.com |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sharon Chen
Regulatory Consultant
Emergo Global Consulting, LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin, Texas 78746 United States
Telephone: (512) 327-9997
Fax: (512)327-9998
LST.AUS.ProjectManagement@ul.com |
| Date Summary Prepared: | September 23, 2021 |
| 5.2 Name of the Device | |
| Trade Name: | ID-500 iRestore Hair Growth System |
| Common Name: | Lamp, non-heating, for promotion of hair growth |
| Classification Name: | General and Plastic Surgery |
| Review Panel: | Physical Medicine (SU) |
| Regulation: | 890.5500 |
| Class: | Class II |
| Product Code: | OAP |
5.3 Equivalence Claimed to Predicate Device
The ID-500 iRestore Hair Growth Systemis equivalent to the iRestore Professional 282 (K 183417), manufactured by Remax Medi-tech (Shenzhen) Corporation.
5.4 Reference Devices
4
REVIAN RED (K173729), manufactured by PhontonMD, Inc.
LaserCap Family of Lasers 300, 224, 120 & 80 (K203826), manufactured by Laser Cap Company
5.5 Indication for Use Statement
ID-500 iRestore Hair Growth System: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV.
5.6 Device Description
The ID-500 iRestore Hair Growth System are two low-level laser/light systems operating at different wavelengths. The ID-500 iRestore Hair Growth System consists of laser and LED operating at 655 ± 10 nanometers. The physical configuration of the device is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The systems operate on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any head shape by means of non-toxic silicone pad. The helmet contains 5-millwatt-diode lasers and 5-milliwatt, super luminescent diodes, that emit red light.
5.7 Substantial Equivalence Discussion
The following table compares the ID-500 iRestore Hair Growth System to the predicate device with respect to indications for use, principles of operation, technological characteristics, 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.
| Table 5.1: Comparison of Characteristics | ||
|---|---|---|
| Attribute | ID-500 iRestore Hair Growth System | Predicate Device |
| 510(k) Number | N/A | K183417 |
| Product Code | OAP | OAP |
| Regulation Number | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Rx/OTC | OTC | OTC |
| Indications for Use | iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have | The iRestore Professional 282 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, |
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| | Norwood-Hamilton
Classifications of IIa to V
and in females who have
Ludgwig-Savin
Classifications of I to II.
All users should also have
Fitzpatrick Skin Types I
to IV. | males who have
Norwood-Hamilton
Classifications of IIa-V
and for both,
Fitzpatrick Classification
of Skin Phototypes I to
IV. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Wearable Mounting | Helmet design | Helmet design |
| Wavelength of LED | 655 ± 10 nm | 655 ± 10 nm |
| Wavelength of Laser | 655 ± 10 nm | 655 ± 10 nm |
| Laser Power for
Classification |