(90 days)
No
The device description and performance studies do not mention any AI or ML components. The system delivers fixed laser emission levels that cannot be altered by the operator, indicating a lack of adaptive or learning capabilities.
Yes.
The device is intended to promote hair growth in individuals with specific classifications of hair loss, which is a therapeutic purpose.
No
The device is indicated to promote hair growth, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical helmet containing lasers and LEDs, operating on line voltage. While software verification and validation are mentioned, this is a standard requirement for devices with embedded software controlling hardware, not indicative of a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "promote hair growth." This is a therapeutic or cosmetic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a low-level laser/light system applied externally to the head. It does not interact with biological specimens in a diagnostic manner.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
Therefore, the ID-510 iRestore Elite falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
OAP
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.
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 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
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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,
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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: (512) 327-9997 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.
4
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
iRestore Elite | ID-500
iRestore Hair
Growth
System | iRestore
Professional
282 | REVIAN
RED | Theradome
LH40 | Capillus 112,
Capillus 244 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Category | Subject
Device | Predicate
Device | Reference
Device | Reference
Device | Reference Device | Reference
Device |
| 510(k)
Number | Not applicable | K213094 | K183417 | K173729 | K180460 | K192012 |
| Manufacturer | Remax Medi-
Tech
(Shenzhen)
Corporation | Remax Medi-
Tech
(Shenzhen)
Corporation | Remax Medi-
Tech
(Shenzhen)
Corporation | PhotonMD,
Inc. | Theradome, Inc. | Capillus |
| Product Code | OAP | OAP | OAP | OAP | OAP | OAP |
| Regulation
Number | 21 CFR
890.5500 | 21 CFR
890.5500 | 21 CFR
890.5500 | 21 CFR
890.5500 | 21 CFR 890.5500 | 21 CFR
890.5500 |
| Indications
for Use | The ID-510
iRestore Elite
is indicated to
promote hair
growth in
males who
have
Norwood-
Hamilton
Classifications | The predicate
Is indicated to
treat
androgenetic
alopecia in
men
It is
designed to
promote | The iRestore
Professional
282
is indicated
for promote
hair and
growth in
females with
to androgenetic
hair alopecia | REVIAN RED
is indicated to
treat
Androgenetic
hair Alopecia
in promote
growth
males
who have
Norwood-Hamilton | The Theradome
LH40
(Theragrow) is an
over the counter
and (OTC)
hair therapeutic
in device
to treat
Androgenetic
Alopecia | The CapillusX
and CapillusX+
laser domes are
intended to treat
Androgenetic
Alopecia and
promotion of
hair growth in
males who have
and Norwood |
| | of IIa-V, and males
in females have
with androgenetic
alopecia who
have Ludwig-
Savin
Classifications
of I-II, and in
both,
Fitzpatrick
Classification
of
Phototypes
to IV. | | who Savin
Classifications
of I-II, males
who have loss and
Norwood-
Hamilton
Classifications
of IIa to V and
in Ludwig-
Savin
Classifications
of I to II. All of
Skin users should
I also
Skin Types I
to IV. | Classifications
promote
treat
Androgenetic
Alopecia
for both, growth
Fitzpatrick
Classification
Skin Savin Scale I-1
I to I-4, II-1, II-2
or frontal
patterns of hair | | hair Hamilton
Classifications
of IIa - V growth in
have of IIA to V
loss and treating
Classifications of
and IIa to V patterns
hair of hair loss and to
in treat
females who
and have
hair (Savin) Scale 1-
in 4. II-1, II-2, or
who frontal; both
Skin Types I to |
| OTC or Rx Only | OTC | OTC | OTC | OTC | OTC | OTC |
| Wavelength
of LED | 625 ± 10 nm
and 655 ± 10 nm | 655 ± 10 nm | 655 ± 10 nm | 620 – 660 nm | No LED | No LED |
| Wavelength
of Laser | 680 ± 10 nm | 655 ± 10 nm | 655 ± 10 nm | No laser | 620 - 660 nm | 678 ± 7 nm |
| Laser Power
for
Classification | Laser Class 3R | Laser Class 3R | Laser Class 3R | Not applicable | Laser Class 3R | Laser Class 3R |
| Time and
Frequency of
Treatment | 12 minutes per
treatment, to be
used daily. | 25 minutes per
treatment, to be
used every day. | 25 minutes per
treatment, to be
used other every
day. | 10 minutes per
treatment, to be
used daily. | 20 minutes per
treatment, to be
used four times
per week. | Six minutes per
treatment, to be
used daily. |
Table 5.1: Comparison of Characteristics
5
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
6
- · 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.