(25 days)
Not Found
No
The summary describes a laser device for hair growth and mentions no features or studies related to AI or ML.
Yes
The device is indicated to "promote hair growth" for a specific medical condition (androgenetic alopecia), which implies a therapeutic intent to improve or treat that condition.
No
The device is indicated to "promote hair growth" and the device description states it is a "diode laser" that provides "full coverage", which indicates a therapeutic purpose rather than a diagnostic one. It does not mention analyzing or detecting any condition.
No
The device description explicitly states it is a "diode laser is configured within an outer helmet and protective inner liner," indicating it is a hardware device. The performance studies also mention testing to standards related to laser safety, basic safety, and EMC, which are relevant to hardware devices.
Based on the provided information, the Hair Boom 69 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "promote hair growth in females with androgenetic alopecia... and in males with androgenetic alopecia..." This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a "diode laser configured within an outer helmet and protective inner liner." This describes a physical device that applies energy (laser light) to the body, not a device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (outside the living body), or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Hair Boom 69's function is to directly interact with the body to stimulate hair growth.
N/A
Intended Use / Indications for Use
The Hair Boom 69 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 of IIa- V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
The Hair Boom 69 diode laser is configured within an outer helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper 1/3 of the head
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)
No clinical performance data was produced for this submission because the Hair Boom 69 is an identical device in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the Hair Boom 69.
The Hair Boom 69 was tested to internationally recognized standards, consistent with the current recommendations adopted by the FDA.
IEC 60825-1 Edition 2.0 2007 - 03 Laser Safety & Classification
IEC 60601-1:2005 (currently called AAMI/ANSI standard) Basic Safety and Essential Performance
IEC 60601-1-2 Edition 1.0. 2010 -04 EMC. This replaces Edition 3.0 2007 - 03 IEC 60601-1-11 Edition 1.0 2014 - 06 Home Use. This replaces Edition 2010 - 04 IEC 62304 Edition 1.1 2015 -06 Software and Life Cycle Processes
ISO 14971 Second edition 2007 - 03 - 01 Application of Risk Management to Medical Devices
ISO 10993-5 2009 -Biological Evaluation of Medical Devices Part 5: Test For In Vitro Cytotoxicity
ISO 10993-10:2010/(R) 2014 -Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
September 30, 2019
Won Tech Co., Ltd. Jake Yu Staff of Regulatory Affairs 64 Techno 8-Ro. Yuseong-gu Daejeon, 34028 KR
Re: K192425
Trade/Device Name: Hair Boom 69, Hair Boom Air, Ulike Hair UpUp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: August 20, 2019 Received: September 5, 2019
Dear Jake Yu:
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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Hair Boom 69
Indications for Use (Describe)
The Hair Boom 69 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 of Ila- V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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K192425
510(k) Summary WON TECH
Date Prepared: August 20, 2019
Submitter's Contact Information
Name: Jake Yu
Address: WON TECH Co., Ltd. 64 Techno 8-Ro. Yuseong-gu. Daejeon, Republic of Korea
Telephone: 82-70-7836-6921
Facsimile: 82-70-934-9491
Trade Name: Hair Boom 69, Hair Boom, Hair Boom Air, Ulike Hair UpUp
Common or Usual Name: Lamp, non-heating, for promotion of hair growth
Classification Name: Infrared lamp per 21 CFR 890.5500
Classification Code: OAP (Laser, comb, hair)
Predicate Device:
| Device Trade Name | Manufacturer |
|---|---|
| Hair Boom 69 (K191154) | WON TECH Co., Ltd. |
Intended Use/ Indications for Use
The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications ofl - II, males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Technological Characteristics
The Hair Boom 69 diode laser is configured within an outer helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.
1 / 3
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Modification
The Hair Boom 69 had minor modifications in additional model names(Hair Boom Air/Ulike Hair UpUp) and helmet and storage base enclosure change. Ear pads and plastic enclosure of the pads were removed for more convenience. The external color of helmet was changed. And the storage base design was changed to match the shape of helmet. The removed parts of helmet did not contain any electrical components. Therefore the change of helmet and storage base enclosure does not affect to the electrical safety and performance.
Performance Data:
No clinical performance data was produced for this submission because the Hair Boom 69 is an identical device in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the Hair Boom 69.
The Hair Boom 69 was tested to internationally recognized standards, consistent with the current recommendations adopted by the FDA.
IEC 60825-1 Edition 2.0 2007 - 03 Laser Safety & Classification
IEC 60601-1:2005 (currently called AAMI/ANSI standard) Basic Safety and Essential Performance
IEC 60601-1-2 Edition 1.0. 2010 -04 EMC. This replaces Edition 3.0 2007 - 03 IEC 60601-1-11 Edition 1.0 2014 - 06 Home Use. This replaces Edition 2010 - 04 IEC 62304 Edition 1.1 2015 -06 Software and Life Cycle Processes
ISO 14971 Second edition 2007 - 03 - 01 Application of Risk Management to Medical Devices
ISO 10993-5 2009 -Biological Evaluation of Medical Devices Part 5: Test For In Vitro Cytotoxicity
ISO 10993-10:2010/(R) 2014 -Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Substantial Equivalence
The Hair Boom 69 is equivalent to the device known as the Hair Boom 69 cleared under 510(k) number, K191154. It is as safe and effective as the predicate device. Both systems, which use red light diode lasers which are classified as class IIIa/3R laser systems by the IEC standard for allowable emission levels, which is a recognized standard by the FDA as well, and the adverse event profile is the same.
Finally, data summarized in the 510(k) notice confirms the safety and efficacy of the Hair Boom 69 for minor modifications, according to special 510(k) process. For these reasons, the Hair Boom 69 satisfies the FDA's standard for substantial equivalence with respect to intended use, technological and design characteristics.
Treatment Protocol
The Hair Boom 69 with an intended for OTC use is the same device as the Hair Boom 69 proposed for OTC use. These devices are one and the same.
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The following Comparison Chart in support of substantial equivalence is provided:
| Hair Boom 69 (K191154) | Hair Boom 69 (Proposed) |
|---|---|
| LLLT Device Type | LLLT Device Type |
| OTC | OTC |
| Intended Use - Androgenetic Alopecia | Intended Use - Androgenetic Alopecia |
| Contain Laser Diodes- 69 Class 3R | Contain Laser Diodes- 69 Class 3R |
| Helmet Design | Helmet Design(removed ear pads and enclosures/Color of helmet enclosure) |
| Wavelength 650 +/- 5 nms. | Wavelength 650 +/- 5 nms. |
| Marketing Clearance -Females & Males OTC | Marketing Clearance -Females & Males OTC |
| Passive Use-Hands Free | Passive Use-Hands Free |
| OAP Classification | OAP Classification |
| Classification Name -Infrared Lamp | Classification Name -Infrared Lamp |
| Common Usage Name - Lamp, Non-Heating | Common Usage Name - Lamp, Non-Heating |
| General & Plastic Surgery Committee | General & Plastic Surgery Committee |
| Skin Phototypes - I- IV | Skin Phototypes - I- IV |
| Hamilton-Norwood Ila-V Hair Loss Classification | |
| Ludwig-Savin I - II Hair Loss Classification | Hamilton-Norwood Ila-V Hair Loss Classification Ludwig-Savin I - II Hair Loss Classification |
| Device Class II | Device Class II |
Conclusion
With the data presented in the Comparison Chart, we believe that this demonstrates the Hair Boom 69, is substantially equivalent to the Hair Boom 69 and based upon the equivalent technological designs of the compared devices, the mild modifications applied and submitted in this application, we request the FDA to clear the device via the 510(k) notice.