Laser Hair Growth Cap
Device Facts
| Record ID | K192627 |
|---|---|
| Device Name | Laser Hair Growth Cap |
| Applicant | Shang FA Biotechnology Co. |
| Product Code | OAP · Physical Medicine |
| Decision Date | Dec 13, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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.
Device Story
Dome-shaped low-level laser therapy (LLLT) device; promotes hair growth via photobiostimulation. Input: electrical power from battery pack. Transformation: 80-280 laser diodes emit 650nm light to scalp. Output: 650nm laser light. Used in home environment; operated by patient. Healthcare provider does not interact with device output; device is OTC. Benefits patient by stimulating hair follicles to promote growth.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2), laser safety (IEC 60825-1), biocompatibility (ISO 10993-5, ISO 10993-10), and usability engineering (IEC 60601-1-6, IEC 62366-1).
Technological Characteristics
LLLT device; 80-280 laser diodes; 650nm wavelength; 5mW per diode. Outer plastic cover with protective inner liner. Battery-powered. Class 3R laser product per IEC 60825-1. Biocompatible materials per ISO 10993-5/10. Complies with IEC 60601-1, 60601-1-2, 60601-1-11, 62133 (battery), and 60950-1 (adapter).
Indications for Use
Indicated for males with androgenic alopecia (Norwood-Hamilton IIa-V) or females with androgenic alopecia (Ludwig-Savin I-II) with Fitzpatrick Skin Phototypes I-IV to promote hair growth.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
{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 seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
December 13, 2019
Shang Fa Biotechnology Co. Chung Ju Zhi General Manager B1F., No. 6, Ln. 1, Oingli St., Tucheng Dist., New Taipei City, 23677 TW
Re: K192627
Trade/Device Name: Laser Hair Growth Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 18, 2019 Received: September 23, 2019
Dear Chung Ju Zhi:
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 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.
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) K192627
Device Name Laser Hair Growth Cap
Indications for Use (Describe)
Laser Hair Growth Cap 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 I-II 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)
### 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."
{3}------------------------------------------------
Traditional 510(k), K192627 510 (k) Summary
## K192627
## 510(k) SUMMARY
| 5.1 | Type of Submission: | Traditional |
|-----|---------------------|----------------------------------------------------|
| 5.2 | Date of Summary: | 12/12/2019 |
| 5.3 | Submitter: | Shang Fa Biotechnology Co. |
| | Address: | B1F., No. 6, Ln. 1, Qingli St., Tucheng Dist., New |
| | | Taipei City 23677, Taiwan (R.O.C.) |
| | Phone: | +886-967-001688 |
| | Contact: | MS. CHUNG JU ZHI |
| | | (info@new-hair.net) |
#### 5.4 Identification of the Device:
| Proprietary/Trade Name: | Laser Hair Growth Cap |
|-------------------------|----------------------------|
| Model Number: | TW280, TW272, TW147, TW08C |
| Regulation Description: | Infrared lamp |
| Review Panel: | General & Plastic Surgery |
| Regulation Number: | 890.5500 |
| Device Class: | II |
| Product Code: | OAP |
#### 5.5 Identification of the Predicate Device:
| Predicate Device Name: | Diode Laser Cap |
|------------------------|-----------------------------------|
| Model Number: | COSMO-030, COSMO-020 |
| Manufacturer: | Cosmo Far East Technology Limited |
| Regulation Number: | 890.5500 |
| Device Class: | II |
| Product Code: | OAP |
| 510(k) Number: | K173678 |
| Predicate Device Name: | Irradiation Aesthetic Device |
| Model: | HairPro |
{4}------------------------------------------------
Traditional 510(k), K192627 510 (k) Summary
| Manufacturer: | Chongqing Peninsula Medical Technology Co., Ltd. |
|--------------------|--------------------------------------------------|
| Regulation Number: | 890.5500 |
| Device Class: | II |
| Product Code: | OAP |
| 510(k) Number: | K171835 |
#### Intended Use/ Indications for Use of the Device 5.6
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.
#### 5.7 Device Description
Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 280, 272, 147, and 80 laser diodes at 650nm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included battery pack.
#### 5.8 Substantial Equivalence Determination
Laser Hair Growth Cap (model number: TW280, TW272, TW147, and TW080) submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation and performance to the cleared Diode Laser Cap, model number: COSMO-030 and COSMO-020 (K173678), and Irradiation Aesthetic Device, model: HairPro (K171835). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
{5}------------------------------------------------
# Traditional 510(k), K192627
| Item | Subject device | Predicate device I | Predicate device II | Substantial<br>equivalence<br>determination |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| 510(k) No. | K192627 | K173678 | K171835 | |
| Proprietary<br>name | Laser Hair Growth<br>Cap | Diode Laser Cap | Irradiation Aesthetic<br>Device | N/A |
| Model number | TW280, TW272,<br>TW147, TW080 | COSMO-030,<br>COSMO-020 | HairPro | |
| Intended use | Laser Hair Growth<br>Cap is indicated to<br>promote hair growth<br>in males with<br>androgenic alopecia<br>who have<br>Norwood-Hamilton<br>classifications of<br>IIa-V or females with<br>androgenic alopecia<br>who have<br>Ludwig-Savin<br>Classifications of I-II<br>and both with<br>Fitzpatrick Skin<br>Phototypes I-IV. | Diode Laser Cap is<br>indicated to promote<br>hair growth in males<br>with androgenic<br>alopecia who have<br>Norwood-Hamilton<br>classifications of<br>IIa~V or females<br>with androgenic<br>alopecia who have<br>Ludwig-Savin<br>Classifications of<br>I~II and both with<br>Fitzpatrick Skin<br>Phototypes I to IV. | The Irradiation<br>Aesthetic Device<br>(Model: HairPro) is<br>indicated to promote<br>hair growth in<br>females with<br>androgenetic<br>alopecia who have<br>Ludwig-Savin<br>Classifications of I -<br>II and males with<br>androgenetic<br>alopecia who have<br>Norwood- Hamilton<br>Classifications of<br>IIa - V and for both,<br>Fitzpatrick<br>Classification of<br>Skin Phototypes I to<br>IV. | SE |
| Type of use | OTC | OTC | OTC | SE |
| Type of light | Low level laser<br>therapy (LLLT);<br>Laser diodes | Low level laser<br>therapy (LLLT);<br>Laser diodes | Low level laser<br>therapy (LLLT);<br>Laser diodes | SE |
| Item | Subject device | Predicate device I | Predicate device II | Substantial<br>equivalence<br>determination |
| Wavelength | 650 nm | 650 nm | 650 nm | SE |
| Amount of laser<br>diodes | TW280: 280<br>TW272: 272<br>TW147: 147<br>TW080: 80 | COSMO-030: 272,<br>COSMO-020: 148 | 81 | SE* |
| *SE determination:<br>Amount of laser diodes of the subject device can be corresponding to that of the<br>predicate devices. The difference in number of diodes is of no consequence and<br>does not affect safety or efficacy as there is a wide range of number of diodes in<br>the predicate devices listed and in other LLLT devices cleared under product<br>code OAP. Thus, we consider the subject device is substantially equivalent to the<br>predicate devices. | | | | |
| Energy of per<br>laser diode | 5mW | 5mW | 5mW | SE |
| Classification<br>according to<br>IEC60825-1 | Class 3R | Class 3R | Class 3R | SE |
| Treatment time | Each treatment: 30<br>min;<br>16 weeks, 3 times<br>per week spaced out<br>every other day | Each treatment: 30<br>min;<br>16 weeks, every<br>other day<br>(indefinite) | Each treatment: 30<br>min;<br>Total treatment: 3<br>times per week | SE* |
| *SE determination:<br>All devices have the same treatment time for 30 mins. The subject device<br>recommends the treatment frequency should be 3 times per week spaced out<br>every other day, and that is equal to the frequency of predicates. LLLT device<br>can be used more than 16 weeks under the condition without exceeding every<br>other day for 30 minutes. Therefore, we consider the subject device is<br>substantially equivalent to the predicate devices | | | | |
| Item | Subject device | Predicate device I | Predicate device II | Substantial<br>equivalence<br>determination |
| Applicable<br>people | Male:<br>Norwood-Hamilton<br>IIa~V<br><br>Female:<br>Ludwig-Savin I~II | Male:<br>Norwood-Hamilton<br>IIa~V<br><br>Female:<br>Ludwig-Savin I~II | Male:<br>Norwood-Hamilton<br>IIa~V<br><br>Female:<br>Ludwig-Savin I~II | SE |
| Applicable skin | Fitzpatrick Skin<br>Phototypes I-IV | Fitzpatrick Skin<br>Phototypes I-IV | Fitzpatrick Skin<br>Phototypes I-IV | SE |
| Design | Cap | Cap | Cap | SE |
| Dimension<br>(L*W*H) | 22*18*9 cm | 22*18*9 cm | 19.9*17.9*8.8 cm | SE* |
| Weight | TW280: 0.32 kg<br>TW272: 0.30 kg<br>TW147: 0.26 kg<br>TW080: 0.25 kg | 0.26 kg | 1000g | SE* |
| Environment for<br>operation | Temperature:<br>5 °C~30°C<br>(41°F~86°F)<br>Humidity: 15%~90% | Temperature:<br>10 °C~30°C<br>(50°F~86°F)<br>Humidity: 20%~80% | Temperature:<br>5 °C~30°C<br>Humidity: ≤80% | SE* |
| Environment for<br>storage | Temperature:<br>-40 °C~70°C<br>(-40°F~158°F)<br>Humidity:<br>10%~100% | Temperature:<br>-10 °C~60°C<br>(14°F~140°F)<br>Humidity: 20%~80% | Temperature:<br>0°C~50°C<br>Humidity: ≤ 85% | SE* |
| *SE determination:<br>The above items, "Dimension", "Weight", "Environment for Operation" and<br>"Environment for Storage" of subject device are slightly different from the<br>predicate devices, but it will not affect the main function and the intended use of<br>the device as they all also comply with IEC 60601-1 requirements Besides the | | | | |
| Item | Subject device | Predicate device I | Predicate device II | Substantial<br>equivalence<br>determination |
| subtle changes of the physical characteristics will not affect the critical functions<br>or the normal use. Therefore, we consider the subject device is substantially<br>equivalent to the predicate devices. | | | | |
| Safety feature | Complied with<br>IEC 60601-1,<br>IEC 60601-1-11,<br>IEC 60601-1-2,<br>IEC 60825-1 | Complied with<br>IEC 60601-1,<br>IEC 60601-1-11,<br>IEC 60601-1-2,<br>IEC 60825-1 | Complied with<br>IEC 60601-1,<br>IEC 60601-1-11,<br>IEC 60601-1-2,<br>IEC 60825-1 | SE |
| | Complied with<br>IEC 62133 (Battery<br>pack) | Complied with<br>IEC 62133 (Battery<br>pack) | | |
| | Complied with<br>IEC 60950-1<br>(Adapter) | Complied with<br>IEC 60950 (Adapter) | | |
| Biocompatibility<br>feature | Complied with ISO<br>10993-5 and ISO<br>10993-10. | Complied with ISO<br>10993-5 and ISO<br>10993-10. | Complied with ISO<br>10993-5 and ISO<br>10993-10. | SE |
{6}------------------------------------------------
Traditional 510(k), K192627
{7}------------------------------------------------
# Traditional 510(k), K192627
{8}------------------------------------------------
#### રું છે Similarity and Difference
Laser Hair Growth Cap (model number: TW280, TW272, TW147, and TW080) has been compared with "Diode Laser Cap, model number: COSMO-030 and COSMO-020" and "Irradiation Aesthetic Device, model: HairPro".
The safety and performance tests have been conducted on subject device, and the results complied with the test requests. Testing to IEC 60825-1 certifies the laser system to classification 3R, same as the predicates.
The subject device has the same safety and performance claims, principle of
{9}------------------------------------------------
operation, and similar technological characteristics as the predicate devices. Although there are slight difference on few specifications between the subject device and the predicate devices, after comparison analyzed considering test results, the difference did not raise any problem of substantial equivalence. No new safety or efficacy concerns are raised due to the minor differences present between devices.
## 5.10 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, Laser Hair Growth Cap (model number: TW280, TW272, TW147, and TW080).
- . Shelf life
- Software validation .
- . Biocompatibility
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
- . Electromagnetic compatibility and electrical safety
- IEC 60601-1:2005+COR.1:2006+COR.2:2007+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-11:2015, 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 60601-1-2:2014, Medical electrical equipment Part 1-2: General । requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 62133:2012 (Battery pack), Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements
{10}------------------------------------------------
for portable sealed secondary cells, and for batteries made from them, for use in portable applications.
- IEC 60950-1:2005+A1:2009+A2:2013 (Adapter), Information । technology equipment - Safety - Part 1: General requirements.
- Performance test .
- IEC 60825-1:2014, Safety of laser products Part 1: Equipment classification and requirements.
- Usability test .
- IEC 60601-1-6:2010+A1:2013, Medical electrical equipment Part 1-6: General requirements forbasic safety and essential performance -Collateral standard: Usability.
- IEC 62366-1:2015, Medical devices Part 1: Application of usability । engineering to medical devices.
All the test results demonstrate Laser Hair Growth Cap (model number: TW280. TW272. TW147. and TW080) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.
## 5.11 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
### 5.12 Conclusion
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that Laser Hair Growth Cap (model number: TW280, TW272, TW147, and TW080) is substantially equivalent to the predicate devices.
