(183 days)
Not Found
No
The summary describes a laser-based hair growth system with basic sensor-based automatic pausing and a timer. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies.
Yes
The device is indicated to "promote hair growth" for a medical condition (androgenetic alopecia) by applying laser light to the scalp, which aligns with the definition of a therapeutic device.
No
The device is described as a hair growth system that uses laser diodes to promote hair growth. It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly states it consists of "laser diodes that are spread throughout the helmet" and describes physical components and their functions (sensors, audible tone, automatic shut off), indicating it is a hardware device with integrated software for control.
Based on the provided information, the iHelmet Hair Growth System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- iHelmet Function: The iHelmet is a device that uses laser light applied externally to the scalp to promote hair growth. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for promoting hair growth in individuals with specific types of alopecia. This is a therapeutic or cosmetic application, not a diagnostic one.
- Device Description: The description focuses on the physical components (laser diodes, helmet) and how it delivers light to the scalp. There is no mention of sample collection or analysis.
Therefore, the iHelmet Hair Growth System falls under the category of a therapeutic or medical device, but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.
Product codes
OAP
Device Description
iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp/Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
iHelmet Hair Growth System has been evaluated the safety and performance by lab bench testing according to the following standards:
- IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety 2005+A1:2012
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests 2001+A1:2006
- IEC 60825-1 Safety of laser products - Part 1: Equipment classification and requirements 2007
- IEC60601-1-11 Medical Electrical Equipment - Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment 2010
- ISO 10993-5 (Cytotoxicity) Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity 2009
- ISO 10993-10 (Sensitization and Irritation) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization 2010
Except for the tests mentioned above, we have conducted the temperature test on the iHelmet Hair Growth System to prove that the highest temperature between iHelmet Hair Growth System and scalp would not exceed 43°C during operation, which is meet the requirement of safety standard IEC 60601-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2017
Slinph Technologies Co., Ltd % Cecilia Ceng Manager Guangzhou Glomed Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, 510663 CN
Re: K162782
Trade/Device Name: Ihelmet Hair Growth System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: March 6, 2017 Received: March 9, 2017
Dear Cecilia Ceng:
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. Iisting 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Jennifer R. Stevenson -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
2
Indications for Use
510(k) Number (if known) K162782
Device Name
iHelmet Hair Growth System (Model: LTD200S)
Indications for Use (Describe)
iHelmet Hair Growth System (Model: LTD200S) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - 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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3
Chapter 6. 510(k) Summary
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 890.5500.
1. Submitter Information
Sponsor Name: Slinph Technologies Co., Ltd. Address: Room 211, Building B, 1970 Cultural and Creative Industrial Park, Minzhi Street, Longhua, Shenzhen, China. Contact name: Zou Jian (General Manager) Tel: +86-158 1556 8501 Fax: 0755-83461353 Email: kevinzou@slinph.com
Application Correspondent:
Contact Person: Ms. Cecilia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Tel: +86-20-61099984 Email: regulatory@glomed-info.com
2. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Lamp, non-heating, for promotion of hair growth |
| Trade Name: | iHelmet Hair Growth System |
| Classification Name: | Infrared lamp per 21 CFR 890.5500 |
| Review Panel: | General & Plastic Surgery |
| Product Code: | OAP |
| Regulation Number: | 21 CFR 890.5500 |
| Regulation Class: | 2 |
3. Predicate Device Information
4
Sponsor: Slinph Technologies Co., LTD Subject Device: iHelmet Hair Growth System, Model: LTD200S File No.: 510(k) submission report (V1.0), Chapter 6
| Sponsor | Capillus, LLC. |
|---|---|
| Common Name | Lamp, non-heating, for promotion of hair growth |
| Trade Name | Capillus272, Capillus202, Capillus82 |
| Classification Name | Infrared lamp per 21 CFR 890.5500 |
| 510(k) number | K153618, K160285, K163170 |
| Review Panel | General & Plastic Surgery |
| Product Code | OAP |
| Regulation Number | 21 CFR 890.5500 |
| Regulation Class | 2 |
4. Device Description
iHelmet Hair Growth System consists of laser diodes that are spread throughout the helmet. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. The product will pause automatically treatment if the sensor detects that the head is not in close proximity to the sensor, and will resume again once close enough. At the end of the treatment, an audible tone beeps to indicate the treatment is over and then the helmet automatically shut off.
5. Intended Use
iHelmet Hair Growth System, Model: LTD200S is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Test Summary 6.
iHelmet Hair Growth System has been evaluated the safety and performance by lab bench testing according to the following standards:
| Standards No. | Standard Title | Version | Date |
|---|---|---|---|
| IEC 60601-1 | Medical Electrical Equipment - Part 1: | ||
| General Requirements for Safety | 2005+A1:2012 | 01/14/2014 | |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: | ||
| General requirements for basic safety | |||
| and essential performance - Collateral | |||
| standard: Electromagnetic | |||
| compatibility - Requirements and tests | 2001+A1:2006 | 09/09/2008 | |
| IEC 60825-1 | Safety of laser products - Part 1: | ||
| Equipment classification and | |||
| requirements | 2007 | 03/2007 | |
| IEC60601-1-11 | Medical Electrical Equipment - Part 1- | 2010 | 03/1/2011 |
5
| | 11: General Requirements for Basic
Safety and Essential Performance -
Collateral Standard: Requirements for
Medical Electrical Equipment and
Medical Electrical Systems Used | | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------------|
| ISO 10993-5
(Cytotoxicity) | Biological evaluation of medical
devices - Part 5: Tests for In Vitro
cytotoxicity | 2009 | 05/05/2010 |
| ISO 10993-10
(Sensitization and
Irritation) | Biological evaluation of medical
devices - Part 10: Tests for irritation
and skin sensitization | 2010 | 03/16/2010 |
Except for the tests mentioned above, we have conducted the temperature test on the iHelmet Hair Growth System to prove that the highest temperature between iHelmet Hair Growth System and scalp would not exceed 43°C during operation, which is meet the requirement of safety standard IEC 60601-1.
7. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | Slinph Technologies Co., Ltd. | Capillus LLC | -- |
| Trade Name | iHelmet Hair Growth System | Capillus272, Capillus202, | |
| Capillus82 | -- | ||
| Classification | |||
| Name | Infrared Lamp | Infrared Lamp | -- |
| 510(k) Number | K162782 | K153618, K160285, K163170 | -- |
| Product Code | OAP | OAP | SE |
| Intended Use / | |||
| Indications for | |||
| Use | iHelmet Hair Growth System | ||
| (Model: LTD200S) is | |||
| indicated to promote hair | |||
| growth in females with | |||
| androgenetic alopecia who | |||
| have Ludwig-Savin | |||
| Classifications I - II, in males | |||
| with androgenetic alopecia | |||
| who have Norwood Hamilton | |||
| Classifications Ila - V and for | |||
| both, Fitzpatrick | |||
| Classification of Skin | |||
| Phototypes of I - IV. | The Capillus272, Capillus202, | ||
| Capillus82 are intended to treat | |||
| Androgenetic Alopecia and | |||
| promote hair growth in males | |||
| who have Norwood Hamilton | |||
| Classifications of Ila to V | |||
| patterns of hair loss and to | |||
| treat Androgenetic Alopecia | |||
| and promote hair growth in | |||
| females who have Ludwig | |||
| (Savin) Scale I-1 to I-4, II-1, II- | |||
| 2, or frontal; both with | |||
| Fitzpatrick Skin Types I to IV. | SE | ||
| Waveform | Visible red laser | Visible red laser | SE |
| Wavelength | 650nm±10nm | 650nm | SE |
| Amounts of | 200 | Capillus272: 272 | SE |
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Sponsor: Slinph Technologies Co., LTD Subject Device: iHelmet Hair Growth System, Model: LTD200S
| Elements of
| Comparison | Subject Device | Predicate Device | Verdic |
|---|---|---|---|
| Laser Lamp | Capillus202: 202 | ||
| Capillus82: 82 | Note 1 | ||
| Energy of per | |||
| Laser Lamp | 4~5mW |