(88 days)
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.
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.
This document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria for a new AI device. Therefore, much of the requested information regarding AI device acceptance criteria and study design is not available in this document.
However, I can extract the relevant information from the provided text about the device and its claimed equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy) for a new AI algorithm. Instead, it demonstrates an acceptance of "substantial equivalence" based on various technical and safety benchmarks compared to a predicate device.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (iHelmet Laser Comb) |
|---|---|
| Intended Use (promote hair growth in specific populations with androgenic alopecia) | Matches predicate: "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 Fitzpatrick Skin Phototypes I-IV." |
| Product Code (OAP) | Matches predicate: OAP |
| Classification (Class II) | Matches predicate: Class II |
| Location for use (OTC) | Matches predicate: OTC |
| Type of Laser (Visible red light-emitting diodes) | Matches predicate: Visible red light-emitting diodes |
| Power (<5mW) | Matches predicate: <5mW |
| Applicable people (Norwood-Hamilton IIa-V (males); Ludwig-Savin I-4, II-1, II-2, or frontal (females)) | Matches predicate |
| Applicable skin (Fitzpatrick Skin Phototypes I-IV) | Matches predicate |
| Appearance design (Comb) | Matches predicate: Comb |
| Safety Compliance (IEC 60601-1-2; IEC 60601-1; IEC 60601-1-11; IEC 60825-1) | Complied with: IEC 60601-1-2; IEC 60601-1; IEC 60601-1-11; IEC 60825-1 |
| Biocompatibility Compliance (ISO 10993-5; ISO 10993-10) | Complied with: ISO 10993-5; ISO 10993-10 |
| Light Class (Difference explained not to raise safety/effectiveness issue) | Subject Device: Class 1; Predicate Device: Class 3R. Note 1 states "they all meet the IEC 60825-1 requirements. So the differences will not raise any safety or effectiveness issue." |
| Amount of Light-emitting diodes (Slight differences explained not to raise safety/effectiveness issue) | Subject Device: 12-16 pcs (model dependent); Predicate Device: 12 pcs. Note 2 states "they are very similar to the predicate device and comply with the regulation requirements, so the differences will not raise any safety or effectiveness any issue." |
| Wavelength (Slight differences explained not to raise safety/effectiveness issue) | Subject Device: 650nm±10nm, 624 nm (model dependent); Predicate Device: 655±5nm. Note 2 states "they are very similar to the predicate device and comply with the regulation requirements, so the differences will not raise any safety or effectiveness any issue." |
| Treatment time (Slight differences explained not to raise safety/effectiveness issue) | Subject Device: 6-11 minutes per treatment (model dependent); Predicate Device: 8 minutes per treatment. Note 2 states "they are very similar to the predicate device and comply with the regulation requirements, so the differences will not raise any safety or effectiveness any issue." |
2. Sample size used for the test set and the data provenance:
- This document describes safety and performance testing against electrical and biocompatibility standards, not a clinical trial with a "test set" in the context of an AI algorithm.
- The tests mentioned in section 7 ("Test Summary") are bench tests against specific IEC and ISO standards (e.g., IEC 60601-1 for electrical safety, IEC 60825-1 for laser safety, ISO 10993-5/10 for biocompatibility). These standards define test methods and acceptance criteria for the device's physical and electrical characteristics, not for clinical performance or AI algorithm validation.
- Therefore, there is no information about a "sample size" of patients or data, nor data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document does not describe the establishment of ground truth by clinical experts for a test set of an AI algorithm. The predicate device and the subject device are low-level laser therapy devices, not AI-powered diagnostic or treatment algorithms.
4. Adjudication method for the test set:
- Not applicable. This document does not describe a test set or an adjudication method for an AI algorithm.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document does not describe an AI device, an MRMC study, or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This document is for a physical medical device (laser comb) and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For the purpose of establishing substantial equivalence, the "ground truth" refers to the established safety and performance of the predicate device and compliance with recognized safety standards for the subject device. There is no AI algorithm requiring a specific type of clinical ground truth.
8. The sample size for the training set:
- Not applicable. This document does not describe an AI device or a training set.
9. How the ground truth for the training set was established:
- Not applicable. This document does not describe an AI device, a training set, or the establishment of ground truth for it.
In summary: The provided document is a 510(k) summary for a low-level laser therapy device (iHelmet Laser Comb), demonstrating its substantial equivalence to a predicate device. It addresses technical safety and performance aspects, not the validation of an AI algorithm with clinical performance metrics. Therefore, most of the questions related to AI-specific study design (sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable to the content of this document.
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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.
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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 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
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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.
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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
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 Requirementsfor Safety | 2005+A1:2012 | 07/09/2014 | Attachment 9 |
| IEC 60601-1-11 | Medical Electrical Equipment -Part 1-11: GeneralRequirements for Basic Safetyand Essential Performance -Collateral Standard:Requirements for MedicalElectrical 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 SystemsUsed | ||||
|---|---|---|---|---|
| IEC 60601-1-2 | Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirementsand tests | Edition 4.02014-02 | 09/17/2018 | Attachment 9 |
| IEC 60825-1 | Safety of laser products - Part1: 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 batteriescontaining alkaline or othernon-acid electrolytes - Safetyrequirements for portablesealed secondary cells, and forbatteries made from them, foruse in portable applications -Part 2: Lithium systems | Edition 1.02017-02 | 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 ofComparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Sponsor | SLINPH TECHNOLOGIES CO., LTD | OMM IMPORTS INC DBA ZEROGRAVITY | -- |
| 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 topromote hair growth in males withandrogenic alopecia who haveNorwood-Hamilton classifications of IIa-V or females with androgenic alopeciawho have Ludwig-Savin Classificationsof I-4, II-1, II-2, or frontal and both with | Laser Hair Therapy is indicated topromote hair growth in males withandrogenic alopecia who haveIIa-V or females with androgenicalopecia who have Ludwig-SavinClassifications of I-4, II-1, II-2, or | SE |
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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
| Elements ofComparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Fitzpatrick Skin Phototypes I-IV. | frontal and both with FitzpatrickSkin Phototypes I-IV. | ||
| Type of Laser | Visible red light-emitting diodes | Visible red light-emitting diodes | SE |
| Light Class | Class I | Class 3R | SENote 1 |
| Amount of Light-emitting diodes | For model SC8 Dual: 16 pcsFor model SC12: 12 pcsFor model SC16 Pro: 16 pcs | 12 pcs | SENote 2 |
| Power | <5mW | <5mW | SE |
| Wavelength | For model SC8 Dual: 650nm±10nm,624 nmFor model SC12: 650nm±10nmFor model SC16Pro: 650nm±10nm | 655±5nm | SENote 2 |
| Treatment time | For SC8 Dual: 11 minutes pertreatment, 3 times per week (everyother day)For SC12: 8 minutes per treatment, 3times per week (every other day)For SC16Por: 6 minutes per treatment,3 times per week (every other day) | 8 minutes per treatment, 3 timesper week (every other day) | SENote 2 |
| Applicablepeople | Norwood- Hamilton Ila~V (males);Ludwig-Savin I-4, II-1, II-2, or frontal(females) | Norwood- Hamilton Ila~V (males);Ludwig-Savin I-4, II-1, II-2, orfrontal (females) | SE |
| Applicable skin | Fitzpatrick Skin Phototypes I- IV | Fitzpatrick Skin Phototypes I- IV | SE |
| Appearancedesign | Comb | Comb | SE |
| Safety | Complied with: IEC 60601-1-2; IEC60601-1; IEC 60601-1- 11; IEC 60825-1 | Complied with: IEC 60601-1-2; IEC60601-1; IEC 60601-1- 11; IEC60825-1 | SE |
| Biocompatibility | Complied with: ISO 10993-5; ISO10993-10 | Complied with: ISO 10993-5; ISO10993-10 | SENote 3 |
Comparison in Detail(s):
Note 1:
Although the "Light Class" of the subject device is different from the predicate device, they all meet the IEC 60825-1 requirements. So the differences will not raise any safety or effectiveness issue.
Note 2:
Although the "Amount of Light-emitting diodes", "Wavelength" and "Treatment time" of the subject device are slightly different from the predicate device's, they are very similar to the predicate
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| 510(k) number | K202631 |
|---|---|
| Sponsor: | SLINPH TECHNOLOGIES CO., LTD |
| Subject Device: | iHelmet Laser Comb, Model: SC8 Dual, SC12, SC16Pro |
| File No.: | 510(k) Summary |
device and comply with the regulation requirements, so the differences will not raise any safety or effectiveness any issue.
Note 3:
The iHelmet Laser Comb is contact directly with the scalp and skin of human body and the contact duration is less than 24 hours. All materials of the iHelmet Laser Comb (Model: SC8 Dual, SC12, SC16Pro) is identical to the materials of the iHelmet Hair Growth System (K162782), the formulation and processing of them also identical and there are no other chemicals have been added to the iHelmet Laser Comb (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).
So, they are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
- ISO 10993-5, Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity; A
- ISO 10993-10, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin A Sensitization.
Finial Conclusion:
The subject device "iHelmet Laser Comb (Model: SC8 Dual, SC12, SC16Pro)" has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device K18329.
9. Summary Prepared Date 5 December 2020
§ 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.