(29 days)
Not Found
No
The 510(k) summary describes a laser-based device for hair growth and does not mention any AI or ML components, image processing, or data analysis related to AI/ML.
Yes
The device is indicated to promote hair growth in individuals with androgenetic alopecia, which is a therapeutic purpose.
No
The device's intended use is to "promote hair growth," which is a treatment function, not a diagnostic one. There is no mention of it analyzing data or providing information for diagnosis.
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 with a laser component, not software only.
Based on the provided information, the Hair Boom Air is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Hair Boom Air Function: The Hair Boom Air is a laser device that applies light directly to the scalp to promote hair growth. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use clearly states it's for promoting hair growth in individuals with specific types of hair loss, not for diagnosing or analyzing biological samples.
- Device Description: The description focuses on the physical components and how the laser interacts with the head, not on analyzing samples.
Therefore, the Hair Boom Air falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hair Boom Air is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of - II, males who have Norwood-Hamilton Classifications of Ila - V and for both. Fitzpatrick Classification of Skin Phototypes I to IV.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
The Hair Boom Air 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
Head Skin
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)
No clinical studies were considered necessary and performed.
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 contains the logo of the U.S. Food & 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.
February 7, 2024
Won Tech Co., Ltd. Yoon Hyunsik Team Leader 64 Techno8-ro, Yuseong-gu Daejeon, 34028 Korea, South
Re: K240064
Trade/Device Name: Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: January 5, 2024 Received: January 9, 2024
Dear Yoon Hyunsik:
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/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
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 (OS) 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 820.30 and 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 (QS) 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-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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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. Hithe -S 2024.02.07 20:11:33 -05'00'
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) K240064
Device Name Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
Indications for Use (Describe)
The Hair Boom Air is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of - II, males who have Norwood-Hamilton Classifications of Ila - V and for both. Fitzpatrick Classification of Skin Phototypes I to 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) | ☒ |
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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 a sans-serif font. The "WON" part of the text is in orange, while the "TECH" part is in gray.
510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
January 05, 2024
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 878.4810, this generic type of the device has been classified as Class II.
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Image /page/5/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" in a sans-serif font. The "WON" portion of the text is in orange, while the "TECH" portion 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
- . K223862 510(k) Number: ● Applicant: WON Tech Co., Ltd Classification Name: Infrared lamp per 21 CFR 890.5500 ●
- Trade Name: Hair Boom Air, Hair Boom 69, Hair Boom, Ulike Hair UpUp
Description of the Device [21 CFR 807.92(a)(4)] ട്.
The Hair Boom Air 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 ofl - II, males who have Norwood-Hamilton Classifications of Ila - 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 | - | K223862 | N/A |
| Manufacturer | WON TECH Co., Ltd. | WON TECH Co., Ltd. | Same |
| Model Name | Hair Boom Air, | ||
| Hair Boom 69, | |||
| Ulike Hair Up Up | Hair Boom Air, | ||
| Hair Boom 69, | |||
| Ulike Hair Up Up | Same | ||
| Indications | |||
| for Use | The Hair Boom 69 is | ||
| indicated to promote hair | |||
| growth in females with | |||
| androgenetic alopecia who | The Hair Boom 69 is | ||
| indicated to promote hair | |||
| growth in females with | |||
| androgenetic | |||
| alopecia who | Same | ||
| 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. | 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. | ||
| Anatomical | |||
| site | Head Skin | Head Skin | Same |
| Design | Helmet Design | Helmet Design | Same |
| Clearance | Females & Males OTC | Females & Males OTC | Same |
| Technical | |||
| 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. | 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. | Same |
| Wavelength | 650 +/- 5nms | 650 +/- 5nms | Same |
| Laser Mode | 30 minutes | 30 minutes | Same |
| Helmet Design | Image: Black helmet | Image: White and blue helmet | Different |
| Color changed | |||
| from | |||
| "White&Blue" to | |||
| "Black" | |||
| Controller | |||
| Design | Image: Black controller | Image: White and blue controller | Different |
| Color changed | |||
| from | |||
| "White&Blue" to | |||
| "Black" | |||
| Adapter | |||
| Connector | Different | ||
| Previously, there | |||
| was separate | |||
| connector part for | |||
| connecting the | |||
| adapter to the | |||
| controller. | |||
| However, after the | |||
| change, the | |||
| connector is | |||
| integrated into the | |||
| adapter, so that the | |||
| adapter and | |||
| controller are | |||
| directly connected. | |||
| Classification | OAP, Infrared Lamp | OAP, Infrared Lamp | Same |
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Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange stylized letter "W" on the left, 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.
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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 "W" inside, followed by the text "WONTECH". The "WON" part of the text is in orange, while the "TECH" part is in gray.
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:
-
- Electrical Safety, Electromagnetic Compatibility Testing
As aim of this submission is limited to the controller design change and to add a new timer mode, the result of electrical safety test reports and standards were demonstrated in the previous cleared submission under K223862
- Electrical Safety, Electromagnetic Compatibility Testing
| Standard
| (Edition) | Description |
|---|---|
| IEC 60601-1:2005/AMD2012 | General requirements for basic safety and essential performance. |
| IEC 60601-1-2:2014 | Electromagnetic disturbances - Requirements and test. |
| IEC 60825-1 Edition 2.0 2007 | Equipment Classifications and Requirements. |
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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 "W" inside it, followed by the text "WONTECH" in a sans-serif font. The "WON" part of the text is in orange, while the "TECH" part is in gray.
2) Software Validation
The Hair Boom Air 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 and to add a new timer mode, the part that contacts the user is same as the previous cleared submission under K223862
| Part | Material | Patient
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|-----------------------------------------|---------------------|--------------------|---------------------------------------|-----------------------|
| Foam lined spacers
inside the helmet | Polyester / Spandex | Intact Skin | Limited
(