(303 days)
Not Found
No
The device description focuses on laser technology and basic sensor-based automation (pausing/resuming treatment). There is no mention of AI, ML, or any data processing that would suggest such capabilities.
Yes
Explanation: The device is indicated to "promote hair growth" for individuals with androgenetic alopecia, which addresses a health condition.
No
The device is indicated to promote hair growth in individuals with androgenetic alopecia, not to diagnose the condition. Its function is to deliver laser treatment.
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, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health status.
- The iHelmet Hair Growth System is a therapeutic device. Its intended use is to directly treat a condition (androgenetic alopecia) by applying laser light to the scalp. It does not analyze any biological samples.
The description clearly indicates it's a device that applies energy (laser light) to the body for a therapeutic purpose, which is the definition of a non-IVD medical device.
N/A
Intended Use / Indications for Use
iHelmet Hair Growth System (LTD88Lite, LTD36Air, LTD160Pro) 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.
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
head (scalp)
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, IEC 60601-1-2, IEC 60825-1, IEC60601-1-11, ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization and Irritation).
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)
K162782, K153618, K160285, K163170
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 23, 2019
Slinph Technologies Co., LTD % S K Manager SK Medical Device International Corp. Suite 52, Floor 16, No. 119 Xing Guang Ying Jing, Shui Ying Road Guangzhou, 51006 CN
Re: K190467
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: November 21, 2019 Received: November 25, 2019
Dear S K:
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 medical devices and radiation-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,
Jessica Mavadia-Shukla 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
Indications for Use
510(k) Number (if known) K190467
Device Name
iHelmet Hair Growth System, Model: LTD88Lite, LTD36Air, LTD160Pro
Indications for Use (Describe)
iHelmet Hair Growth System (LTD88Lite, LTD36Air, LTD160Pro) 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.
| 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. SK Tel: +86-18620793542 Email: medical-device@qq.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 |
Predicate Device Information 3.
Predicate device 1
4
Sponsor: Slinph Technologies Co., LTD Subject Device: iHelmet Hair Growth System, Model: LTD88Lite, LTD 36Air, LTD160Pro File No.: 510(k) submission report (V1.0), Chapter 6
| Sponsor | iHelmet Hair Growth System |
|---|---|
| Common Name | Lamp, non-heating, for promotion of hair growth |
| Trade Name | LTD200S |
| Classification Name | Infrared lamp per 21 CFR 890.5500 |
| 510(k) number | K162782 |
| Review Panel | General & Plastic Surgery |
| Product Code | OAP |
| Regulation Number | 21 CFR 890.5500 |
| Regulation Class | 2 |
| Predicate device 2 | |
|---|---|
| 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 |
Device Description 4.
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: LTD88Lite, LTD36Air, LTD160Pro) 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.
5
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 | 07/09/2014 | |
| 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 | Edition 4.0 2014- | ||
| 02 | 06/27/2016 | ||
| IEC 60825-1 | Safety of laser products - Part 1: | ||
| Equipment classification and | |||
| requirements | 2007-03 | 07/09/2014 | |
| 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 | 2010 | 06/27/2016 | |
| ISO 10993-5 | |||
| (Cytotoxicity) | Biological evaluation of medical | ||
| devices - Part 5: Tests for In Vitro | |||
| cytotoxicity | 2009 | 12/23/2016 | |
| ISO 10993-10 | |||
| (Sensitization and | |||
| Irritation) | Biological evaluation of medical | ||
| devices - Part 10: Tests for irritation | |||
| and skin sensitization | 2010 | 07/26/2016 |
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 1 | Predicate Device 2 | Verdict |
|---|---|---|---|---|
| Company | Slinph Technologies | |||
| Co., Ltd. | Slinph Technologies | |||
| Co., Ltd. | Capillus LLC | -- | ||
| Trade Name | iHelmet Hair Growth | |||
| System | iHelmet Hair Growth | |||
| System | Capillus272, | |||
| Capillus202, | ||||
| Capillus82 | -- | |||
| Classification | ||||
| Name | Infrared Lamp | Infrared Lamp | Infrared Lamp | -- |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device 1 | Predicate Device | |
| 2 | Verdict | |||
| 510(k) Number | Applying | K162782 | K153618, | |
| K160285, K163170 | -- | |||
| Product Code | OAP | OAP | OAP | SE |
| Intended Use / | ||||
| Indications for | ||||
| Use | iHelmet Hair Growth | |||
| System (Model: | ||||
| LTD88Lite, | ||||
| LTD36Air, | ||||
| LTD160Pro) 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. | 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
1-4, II-1, II-2, or
frontal; both with
Fitzpatrick Skin
Types I to IV. | SE |
| Waveform | Visible red laser | Visible red laser | Visible red laser | SE |
| Wavelength | 650nm±10nm | 650nm±10nm | 650nm | SE |
| Amounts of Laser
Lamp | LTD88Lite: 88
LTD36Air: 36
LTD160Pro: 160 | 200 | Capillus272: 272
Capillus202: 202
Capillus82: 82 | SE
Note 1 |
| Energy of per
Laser Lamp | 45mW | 45mW |