(78 days)
No
The summary describes a low-level laser therapy device for hair growth and does not mention any AI or ML components or functionalities.
Yes
The device is intended to "promote hair growth in males with androgenic alopecia" and "females with androgenic alopecia," which indicates a therapeutic purpose.
No
The device description and intended use clearly state that the Laser Cap is designed to promote hair growth by emitting laser light. There is no mention of it being used for diagnosis, measurement, or detection of any medical condition.
No
The device description explicitly states it is a "hand-held cap-shaped low level laser therapy device" and mentions hardware components like "82 laser diodes," indicating it is a physical device, not software only.
No, this device 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Laser Cap Function: The Laser Cap is a device that applies low-level laser therapy directly to the scalp on the body (in vivo) to stimulate hair growth. It does not analyze any biological samples.
The provided information clearly describes a therapeutic device used externally on the body, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
Laser Cap 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-II and both with Skin Phototypes I-IV.
Product codes
OAP
Device Description
Laser Cap is a hand-held cap-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the cap covers the user's scalp to ensure the laser light reaches the user's scalp. Model Hat-01 contains 82 laser diodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head
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)
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of Laser cap was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The testing was performed to, and passed, including:
- ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10:2021, Biological Evaluation of Medical Devices –Part 10: Tests for Skin Sensitization
- ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices Part 23: Tests for irritation
- Electrical and EMC Safety: Electrical safety and EMC safety testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- 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 medical electrical systems used in the home healthcare environment
- 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
In addition, testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate devices.
Summary: Based on the above performance as documented in this application, Laser cap was found to have a safety and effectiveness profile that is same as the predicate device.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 24, 2023
Hubei YJT Technology Co.,Ltd % Gamma Zhang RA Manager Shenzhen Tacro Medical technology services Co., Ltd. Suite 405, Bldg. A Nanfeng, No.4093 Liuxian Blvd., Nanshan Dist. Shenzhen, Guangdong 510000 China
Re: K232356
Trade/Device Name: Laser Cap, Model: Hat-01 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: August 7, 2023 Received: August 7, 2023
Dear Gamma Zhang:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
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,
Tanisha L. Hithe Tanisha L. J 2023.10.24 Hithe -S 11:29:35 -04'00' Tanisha Hithe 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
3
Indications for Use
510(k) Number (if known) K232356
Device Name Laser Cap
Indications for Use (Describe)
Laser Cap 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-II and both with 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2023-08-07
I. Submitter
Hubei YJT Technology Co.,Ltd. Room1-4, 8F,Block7,Guannan Fuxing Pharmaceutical Park, No.62 Optical Valley Ave, East Lake High-tech Development Zone, Wuhan, Hubei Province, China Tel.: 027-87771565
Jiali Xie (RA engineer) Tel: +86 15327223070 Email: 528149645@gg.com
II. Correspondent Consultant
Shenzhen Tacro Medical technology services Co., Ltd. Suite 405, Bldg. A Nanfeng, No.4093 Liuxian Blvd., Nanshan Dist., Shenzhen, Guangdong
Gamma Zhang (RA manager) Tel: +86 13433933949 Email: wbzhang@tacro.cn
III. Device
Type of 510(k): Traditional Common Name: Laser cap Trade Name: Laser cap Model: Hat-01 Classification Name: Laser, Comb, Hair Regulation Number: 21 CFR 890.5500 Review Panel: Physical Medicine Regulatory Class: II Product Code: OAP
IV. Predicate Device
| Applicant | Predicate Device | 510(k) Number |
|---|---|---|
| Transdermal Cap, | ||
| Inc. | LaserCap Family of Lasers | |
| 300, 224, 120 & 80 | K203826 |
5
510(k)s –510(k) Summary
| Shenzhen CosBeauty
Technology Co., Ltd. | LLLT Laser Hair Growth Cap,
Model: Hair Care 88, Hair Care
135, Hair Care
210 | K213447 |
| -------------------------------------------- | ---------------------------------------------------------------------------------------- | --------- |
|---|
V. Device Description
Laser Cap is a hand-held cap-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the cap covers the user's scalp to ensure the laser light reaches the user's scalp. Model Hat-01 contains 82 laser diodes.
VI. Indications for Use
Laser Cap 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-II and both with Skin Phototypes I-IV.
6
VII.Comparison of Technological Characteristics With the Predicate Device
Laser cap raises no safety or efficacy concerns when compared to the predicate devices. A technical comparison to the predicate is provided below:
| Comparison
| Elements | Subject Device | Predicate Device I | Predicate Device II | Comparison |
|---|---|---|---|---|
| K Number | Pending | K203826 | K213447 | / |
| Trade name | Laser Cap | LaserCap Family of | ||
| Lasers, Models 300, | ||||
| 224, 120 and 80 | LLLT Laser Hair | |||
| Growth Cap, Model: | ||||
| Hair Care 88, Hair Care | ||||
| 135, Hair Care 210 | / | |||
| Model | Hat-01 | 80 | Hair Care 88 | / |
| Classification | ||||
| name | Laser, Comb, Hair | Laser, Comb, Hair | Laser, Comb, Hair | / |
| Product code | OAP | OAP | OAP | / |
| Intended | ||||
| use/Indications | ||||
| for Use | Laser Cap 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-II | ||||
| and both with Skin | ||||
| Phototypes I-IV. | The LaserCap Family of | |||
| Lasers, models 300, 224, | ||||
| 120 and 80 are indicated | ||||
| to promote hair growth | ||||
| in females with | ||||
| androgenetic alopecia | ||||
| who have Ludwig-Savin | ||||
| Classifications of I-II, | ||||
| and males who have | ||||
| Norwood-Hamilton | ||||
| Classifications of IIa-V | ||||
| and for both, Fitzpatrick | ||||
| Skin Phototypes I to IV. | LLLT Laser Hair | |||
| Growth Cap 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-II | ||||
| and both with | ||||
| Fitzpatrick Skin | ||||
| Phototypes I-IV. | Same | |||
| Location for use | Head | Head | Head | Same |
| Type of laser | Laser diodes | Laser diodes | Laser diodes | Same |
| Wavelength | 650nm | 650nm±5nm | 650nm±10nm | Same |
| Amount of laser | ||||
| diodes | 82 | 80 | 88 | Same |
| Energy of per | ||||
| laser diode | 5mW±20% | 5mW | 5mW ±20% | Same |
| Classification | ||||
| according to IEC | ||||
| 60825-1 | Class 3R | Class 3R | Class 3R | Same |
| Treatment time | 16 weeks, for 30- | |||
| minute treatment times | 16 weeks, for 30-minute | |||
| treatment times | 16 weeks, for 30-minute | |||
| treatment times | Same | |||
| Treatment | ||||
| frequency | 3 times per week | |||
| spaced out every other | ||||
| day | 3 times per week spaced | |||
| out every other day | 3 times per week | |||
| spaced out every other | ||||
| day | Same | |||
| 510(k)s =510(k) Summary | ||||
| Comparison | ||||
| Elements | Subject Device | Predicate Device I | Predicate Device II | Comparison |
| Applicable people | Norwood- | |||
| Hamilton IIa~V | ||||
| (males) | ||||
| Ludwig-Savin I~II | ||||
| (females) | Norwood-Hamilton | |||
| IIa~V (males) | ||||
| Ludwig-Savin I~II | ||||
| (females) | Norwood-Hamilton | |||
| IIa~V (males) | ||||
| Ludwig-Savin I~II | ||||
| (females) | Same | |||
| Applicable skin | Fitzpatrick Skin | |||
| Phototypes I-IV | Fitzpatrick Skin | |||
| Phototypes I-IV | Fitzpatrick Skin | |||
| Phototypes I-IV | Same | |||
| Shape design | Helmet | Helmet | Helmet | Same |
| Safety feature | Complied | |||
| with | ||||
| IEC60601-1, | ||||
| IEC60601-1- | ||||
| 11, | ||||
| IEC60601-1- | ||||
| 2 and | ||||
| IEC60825-1 | Complied with | |||
| IEC60601-1, | ||||
| IEC60601-1- | ||||
| 11, IEC60601- | ||||
| 1-2 and | ||||
| IEC60825-1 | Complied | |||
| with | ||||
| IEC60601-1, | ||||
| IEC60601-1- | ||||
| 11, | ||||
| IEC60601-1- | ||||
| 2 and | ||||
| IEC60825-1 | Same | |||
| Biocompatibility | All body- | |||
| contacting | ||||
| materials are | ||||
| complied | ||||
| with | ||||
| ISO10993-5 | ||||
| and ISO | ||||
| 10993-10, | ||||
| ISO 10993- |
-
| All body-
contacting
materials are
complied with
ISO10993-5
and ISO
10993-10, ISO
10993-23. | All body-
contacting
materials are
complied with
ISO10993-5
and ISO
10993-10,
ISO 10993-
23. | Same |
7
8
VIII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of Laser cap was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The testing was performed to, and passed, including:
-
ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2021, Biological Evaluation of Medical Devices –Part 10: Tests for Skin Sensitization
-
ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices Part 23: Tests for irritation
2) Electrical and EMC Safety
Electrical safety and EMC safety testing was performed to, and passed, the following standards:
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
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 medical electrical systems used in the home healthcare environment
-
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
In addition, testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate devices.
Summarv
Based on the above performance as documented in this application, Laser cap was found to have a safety and effectiveness profile that is same as the predicate device.
VIII. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, Laser cap is to be concluded same to its predicate devices.