(88 days)
No
The device description and performance studies focus on the physical characteristics and safety standards of a low-level laser therapy device, with no mention of AI or ML capabilities.
Yes.
The device is intended to promote hair growth in individuals with androgenic alopecia, which is a therapeutic purpose.
No
The device is intended to promote hair growth, which is a therapeutic rather than a diagnostic function. It does not identify, detect, or provide information for the diagnosis of a disease or condition.
No
The device description explicitly states it is a "comb-shaped low level laser therapy (LLLT) device" and includes physical components like a main unit, charging dock, power cable, and a built-in battery. It also mentions emitting laser light and having comb teeth. This indicates it is a hardware device with a physical form factor and functional components beyond just software.
Based on the provided information, the iHelmet Laser Comb is not an IVD (In Vitro Diagnostic) device.
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 about a person's health.
- iHelmet Laser Comb Function: The iHelmet Laser Comb is a device that applies low-level laser therapy directly 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 androgenic alopecia, not for diagnosing or monitoring a condition through in vitro analysis.
- Device Description: The description details a physical device that emits light and is applied externally.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, reagents, or diagnostic procedures.
Therefore, the iHelmet Laser Comb falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iHelmet Laser Comb is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ha-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
Product codes
OAP
Device Description
The iHelmet Laser Comb is a comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth. The device provides distributed laser to the scalp at 650+/-10nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Laser Hair Therapy is designed as handheld product, and it consists of main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the treatment is completed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The iHelmet Laser Comb (Model: SC8 Dual, SC12, SC16Pro) has been evaluated the safety and performance by lab bench testing according to the following standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60825-1, IEC 62133-2, ISO 10993-5, ISO 10993-10
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a circular seal with an abstract design of human figures. To the right of the seal, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG ADMINISTRATION' are written in a bold, sans-serif font. The words 'FOOD & DRUG' are on the top line, and the word 'ADMINISTRATION' is on the bottom line.
December 8, 2020
Slinph Technologies Co., Ltd % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichung Road, Huangpu District, Guangzhou, Guangdong 51006 China
Re: K202631
Trade/Device Name: iHelmet Laser Comb Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 6, 2020 Received: September 11, 2020
Dear Cassie Lee:
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.
1
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 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,
Purva Pandya 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) K202631
Device Name
iHelmet Laser Comb (Model: SC8 Dual, SC12, SC16Pro)
Indications for Use (Describe)
The iHelmet Laser Comb is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ha-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes 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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510(k) Summary (K202631)
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
- Phone: +86-0755-83461353 �
- � Fax: +86-0755-83461353
- Contact Person (including title): Jian Zou (General Manager) �
- E-mail: Kevinzou@slinph.com �
Application Correspondent: 2.
- � Contact Person: Ms. Cassie Lee
- Guangzhou GLOMED Biological Technology Co., Ltd. �
- � Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China
- � Tel: +86 20 8266 2446
- Email: regulatory@glomed-info.com �
Subject Device Information 3.
| Type of 510(k): | Traditional |
|---|---|
| Trade Name: | iHelmet Laser Comb |
| Classification Name: | Laser, comb, hair |
| Review Panel: | General & Plastic Surgery |
| Product Code: | OAP |
| Regulation Number: | 890.5500 |
| Regulation Class: | 2 |
Predicate Device Information 4.
4
510(k) number K202631 Sponsor: SLINPH TECHNOLOGIES CO., LTD Subject iHelmet Laser Comb, Model: SC8 Dual, SC12, SC16Pro Device: File No.: 510(k) Summary
Sponsor: OMM IMPORTS INC DBA ZERO GRAVITY Classification Name: Infrared Lamp Trade Name: Laser Hair Therapy 510(K) Number: K183329 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 890.5500 Regulation Class: 2
5. Device Description
The iHelmet Laser Comb is a comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth. The device provides distributed laser to the scalp at 650+/-10nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Laser Hair Therapy is designed as handheld product, and it consists of main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the treatment is completed.
6. Intended Use
The iHelmet Laser Comb is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of 1-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
7. Test Summary
The iHelmet Laser Comb (Model: SC8 Dual, SC12, SC16Pro) has been evaluated the safety and performance by lab bench testing according to the following standards:
| Standards No. | Standard Title | Version | Date | Detail |
|---|---|---|---|---|
| IEC 60601-1 | Medical Electrical Equipment - | |||
| Part 1: General Requirements | ||||
| for Safety | 2005+A1:2012 | 07/09/2014 | Attachment 9 | |
| IEC 60601-1-11 | Medical Electrical Equipment - | |||
| Part 1-11: General | ||||
| Requirements for Basic Safety | ||||
| and Essential Performance - | ||||
| Collateral Standard: | ||||
| Requirements for Medical | ||||
| Electrical Equipment and | Edition 2.0, | |||
| 2015-01 | 06/27/2016 | Attachment 9 |
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510(k) number K202631
Sponsor: SLINPH TECHNOLOGIES CO., LTD
Subject iHelmet Laser Comb, Model: SC8 Dual, SC12, SC16Pro Device:
File No.: 510(k) Summary
| | Medical Electrical Systems
Used | | | |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|------------|--------------|
| 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 | 09/17/2018 | Attachment 9 |
| IEC 60825-1 | Safety of laser products - Part
1: Equipment classification,
and requirements [Including:
Technical Corrigendum 1
(2008), Interpretation Sheet 1
(2007), Interpretation Sheet 2
(2007)] | Edition 2.0,
2007-03 | 07/09/2014 | Attachment 9 |
| IEC 62133-2 | Secondary cells and batteries
containing alkaline or other
non-acid electrolytes - Safety
requirements for portable
sealed secondary cells, and for
batteries made from them, for
use in portable applications -
Part 2: Lithium systems | Edition 1.0
2017-02 | 12/23/2019 | Attachment 9 |
Comparison to Predicate Device 8.
Compared with the predicate device, the subject device has similar in the design principle, the intended use, the indications for use, functions and applicable standards. The differences between the subject device and the predicate device do not raise any new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Sponsor | SLINPH TECHNOLOGIES CO., LTD | OMM IMPORTS INC DBA ZERO | |
| GRAVITY | -- | ||
| Device name | iHelmet Laser Comb (Model: SC8 Dual, | ||
| SC12, SC16Pro) | Laser Hair Therapy | -- | |
| K Number | Pending | K183329 | -- |
| Product Code | OAP | OAP | SE |
| Classification | Class II | Class II | SE |
| Location for use | OTC | OTC | SE |
| Intended Use | The iHelmet Laser Comb is indicated to | ||
| promote hair growth in males with | |||
| androgenic alopecia who have | |||
| Norwood-Hamilton classifications of IIa- | |||
| V or females with androgenic alopecia | |||
| who have Ludwig-Savin Classifications | |||
| of I-4, II-1, II-2, or frontal and both with | Laser Hair Therapy is indicated to | ||
| promote hair growth in males with | |||
| androgenic alopecia who have | |||
| IIa-V or females with androgenic | |||
| alopecia who have Ludwig-Savin | |||
| Classifications of I-4, II-1, II-2, or | SE |
6
510(k) number K202631
Sponsor: SLINPH TECHNOLOGIES CO., LTD
Subject iHelmet Laser Comb, Model: SC8 Dual, SC12, SC16Pro Device:
File No.: 510(k) Summary
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Fitzpatrick Skin Phototypes I-IV. | frontal and both with Fitzpatrick | ||
| Skin Phototypes I-IV. | |||
| Type of Laser | Visible red light-emitting diodes | Visible red light-emitting diodes | SE |
| Light Class | Class I | Class 3R | SE |
| Note 1 | |||
| Amount of Light- | |||
| emitting diodes | For model SC8 Dual: 16 pcs | ||
| For model SC12: 12 pcs | |||
| For model SC16 Pro: 16 pcs | 12 pcs | SE | |
| Note 2 | |||
| Power |