(126 days)
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 Classification of Skin Phototypes I to IV.
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.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that the device meets them.
The document is a 510(k) Premarket Notification from the FDA, and it focuses on demonstrating substantial equivalence to a previously cleared predicate device (K192425). It explicitly states:
- "No clinical studies were considered necessary and performed."
- The aim of the submission is "limited to the controller design change."
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or MRMC studies for this submission. The basis for clearance is that the device, with its minor design change to the controller, is substantially equivalent to an already cleared device, and thus, new performance studies were not required by the FDA for this particular submission.
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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 logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 28, 2023
Won Tech Co., Ltd. Hyun Yoon General Manager 64 Techno 8-Ro, Yuseong-gu Daejeon, 34028 Korea. South
Re: K223862
Trade/Device Name: Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: March 29, 2023 Received: March 29, 2023
Dear Hyun Yoon:
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
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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,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, sans-serif font. The text is black and appears against a white background. The name is likely a person's name, and the "-S" could be an initial or abbreviation.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223862
Device Name Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
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 IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Type of Use (Select one or both, as applicable)
| Research Use (Part 21 CFR 361) Subject to Premarket Review |
|---|
| For Third Party Contracting (21 CFR 361 Subject to Premarket Review) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the word "WONTECH" in orange and gray. The "WON" part of the word is in orange, while the "TECH" part is in gray.
510(k) Summary
[As required by 21 CFR 807.92]
K223862
1. Date Prepared [21 CFR 807.92(a)(a)]
April 25th, 2023
Submitter's Information & Contact Person [21 CFR 807.92(a)(1)] 2.
- Name of Manufacturer: WON TECH Co., Ltd.
- Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, 34028, Republic of Korea - Contact Name: Hyun Sik Yoon - Telephone No.: +82-10-6750-5346 - Fax No.: +82-70-7836-0110 - Email Address: yoonhs21@wtlaser.com
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)|
Common name: Lamp, non-heating, for promotion of hair growth Trade name: Hair Boom 69, Hair Boom Air, Hair Boom, Ulike Hair UpUp
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Infrared lamp | 890.5500 | OAP |
As stated in 21 CFR, parts 890.5500, this generic type of the device has been classified as Class II.
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Image /page/4/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH" in orange and gray. The "WON" part of the text is in orange, while the "TECH" part is in gray.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)|
The identified predicate devices within this submission are shown as follow:
Predicate device
| • 510(k) Number: | K192425 |
|---|---|
| • Applicant: | Hair Boom 69 |
| • Classification Name: | Infrared lamp per 21 CFR 890.5500 |
| • Trade Name: | Hair Boom 69, Hair Boom Air, Hair Boom, Ulike Hair UpUp |
5. Description of the Device [21 CFR 807.92(a)(4)]
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.
6. Indications for Use [21 CFR 807.92(a)(5)]
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 Classification of Skin Phototypes I to IV.
7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
There are no significant differences between the previous and renewed Hair Boom 69 that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.
| Proposed Device | Predicate Device #1 | SE Decision | |
|---|---|---|---|
| K Number | K223682 | K192425 | N/A |
| Manufacturer | WON TECH Co., Ltd. | WON TECH Co., Ltd. | Same |
| Model Name | Hair Boom 69,Hair Boom Air,Ulike Hair Up Up | Hair Boom 69,Hair Boom Air,Ulike Hair Up Up | Same |
| Indications forUse | The Hair Boom 69 isindicated to promote hairgrowth in females withandrogenetic alopecia | The Hair Boom 69 isindicated to promote hairgrowth in females withandrogeneticalopecia | Same |
| Proposed Device | Predicate Device #1 | SE Decision | |
| who have Ludwig-SavinClassifications of - II,males who haveNorwood-HamiltonClassifications of Ila - Vand for both, FitzpatrickClassification of SkinPhototypes I to IV. | who have Ludwig-SavinClassifications of - II,males who haveNorwood-HamiltonClassifications of Ila - Vand for both, FitzpatrickClassification of SkinPhototypes I to IV. | ||
| Anatomical site | Head Skin | Head Skin | Same |
| Design | Helmet Design | Helmet Design | Same |
| Clearance | Females & Males OTC | Females & Males OTC | Same |
| Technicalcharacteristics | The Hair Boom 69 diodelaser is configured withinan outer helmet andprotective inner liner. Theuse of diode lasersprovides for a fullcoverage of the upper 1/3of the head; i.e., the areacommonly covered withstylized hair. At the end ofthe therapy cycle, thesystem signals thattherapy is complete andready to be powereddown, by emitting anaudible beep pattern. | The Hair Boom 69 diodelaser is configured withinan outer helmet andprotective inner liner. Theuse of diode lasersprovides for a fullcoverage of the upper 1/3of the head; i.e., the areacommonly covered withstylized hair. At the end ofthe therapy cycle, thesystem signals that therapyis complete and ready tobe powered down, byemitting an audible beeppattern. | Same |
| Wavelength | 650 +/- 5nms | 650 +/- 5nms | Same |
| Laser Mode | 30 minutes only | 30 minutes only | Same |
| Helmet Design | Image: Helmet Design | Image: Helmet Design | Same |
| ControllerDesign | Image: Controller Design | Image: Controller Design | DifferentDesign Change.The controller ofthe predicatedevice |
| Proposed Device | Predicate Device #1 | SE Decision | |
| (K192425)isoctagon shapedand the start /stop button,power button,and hold buttonwere placed onthe front panel ofthe controller.However, therenewed device,its shape hasbeen changedfrom octagon tocircle. As thedesign changesto a circledshape, theexisting start /stop button andpower button arelocated on thefront sidetogether as sameas before, but thehold button isarranged on theside panel. | |||
| Classification | OAP, Infrared Lamp | OAP, Infrared Lamp | Same |
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Image /page/5/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular design with two white curved lines inside, resembling a stylized "W". To the right of the circular design, the word "WONTECH" is written in a sans-serif font. The "WON" part of the word is in orange, while the "TECH" part is in gray.
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Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with a stylized "W" inside, followed by the text "WONTECH" in a sans-serif font. The "WON" portion of the text is orange, while the "TECH" portion is gray.
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Image /page/7/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular icon with a stylized white "W" inside, followed by the text "WONTECH". The "WON" part of the text is in orange, while the "TECH" part is in gray. The overall design is modern and clean.
Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
The WON TECH Co., Ltd. claims conformity with the following Electrical & Mechanical Safety, and Electromagnetic Compatibility standards:
1) Electrical Safety, Electromagnetic Compatibility Testing
As aim of this submission is limited to the controller design change, the result of electrical safety test reports and standards were demonstrated in the previous cleared submission under K192425
| Standard(Edition) | Description |
|---|---|
| IEC 60601-1:2005/AMD2012 | Medical electrical equipment – Part 1: General requirements forbasic safety and essential performance |
| IEC 60601-1-2:2014 | Medical electrical equipment – Part 1-2: General requirementsfor basic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests |
| IEC 60825-1 Edition 2.0 2007 | Safety of laser products - Part 1: Equipment classification andrequirements |
2) Software Validation
The Hair Boom 69 contains MINOR level of concern software was designed and developed according to a software development process and was verified and validated.
The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.
3) Biocompatibility
As aim of this submission is limited to the controller design change, the part that contacts the user is same as the previous cleared submission under K192425
| Part | Material | PatientContact | Duration of Contactby ISO 10993-1 | Bio-compatibility |
|---|---|---|---|---|
| Foam lined spacersinside the helmet | Polyester / Spandex | Intact Skin | Limited(< 24 hours) | Yes |
- The material is same as the predicate device (K192425) as they use same helmet design
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Image /page/8/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized white "W" inside of it. To the right of the circle is the text "WONTECH", with "WON" in orange and "TECH" in gray.
Clinical Test Summary [21 CFR 807.92(b)(2)]
No clinical studies were considered necessary and performed.
Conclusion [21 CFR 807.92(b)(3)]
In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WON TECH Co., Ltd. concludes that the Hair Boom 69 is substantially equivalent to previous device (Hair Boom 69, K192425) as described herein.
§ 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.