K Number

Device Name

Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp

Manufacturer

Won Tech Co., Ltd.

Date Cleared

2023-04-28

(126 days)

Product Code

OAP

Regulation Number

890.5500

Intended 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 Classification of Skin Phototypes I to IV.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K192425

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser-based device with a timer and audible signal, with no mention of AI/ML terms, image processing, or data sets for training/testing.

Therapeutic

Yes
The device is indicated to "promote hair growth" for a specific medical condition (androgenetic alopecia), which is a therapeutic purpose.

Diagnostic

No
The device is described as promoting hair growth and providing therapy, but there is no mention of it diagnosing a condition or disease.

SaMD (Software as a Medical Device)

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 containing a laser and a physical structure.

IVD (In Vitro Diagnostic)

Based on the provided information, the Hair Boom 69 is not an IVD (In Vitro Diagnostic).

Here's why:

IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that the Hair Boom 69 is a laser device applied externally to the head for hair growth. It does not involve the analysis of any biological samples like blood, urine, or tissue.
The device description and intended use focus on a physical treatment. The device uses diode lasers to stimulate hair growth, which is a therapeutic intervention, not a diagnostic test.

Therefore, the Hair Boom 69 falls under the category of a therapeutic device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

OAP

Device Description

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

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 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.

K192425

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

Regulation Number and Section

§ 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.

Summary

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

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

Indications for Use

510(k) Number (if known) K223862

Device Name Hair Boom 69, Hair Boom Air, Ulike Hair UpUp

Indications for Use (Describe)

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.

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)]

6. Indications for Use [21 CFR 807.92(a)(5)]

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 for
Use	The Hair Boom 69 is
indicated to promote hair
growth in females with
androgenetic alopecia	The Hair Boom 69 is
indicated to promote hair
growth in females with
androgenetic
alopecia	Same
Proposed Device	Predicate Device #1	SE Decision
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.	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.
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 only	30 minutes only	Same
Helmet Design	Image: Helmet Design	Image: Helmet Design	Same
Controller
Design	Image: Controller Design	Image: Controller Design	Different
Design Change.
The controller of
the predicate
device
Proposed Device	Predicate Device #1	SE Decision
		(K192425)is
octagon shaped
and the start /
stop button,
power button,
and hold button
were placed on
the front panel of
the controller.
However, the
renewed device,
its shape has
been changed
from octagon to
circle. As the
design changes
to a circled
shape, the
existing start /
stop button and
power button are
located on the
front side
together as same
as before, but the
hold button is
arranged on the
side panel.
Classification	OAP, Infrared Lamp	OAP, Infrared Lamp	Same

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.

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.

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 for
basic safety and essential performance
IEC 60601-1-2:2014	Medical electrical equipment – Part 1-2: General requirements
for 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 and
requirements

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 | Patient
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|-----------------------------------------|---------------------|--------------------|---------------------------------------|-----------------------|
| Foam lined spacers
inside the helmet | Polyester / Spandex | Intact Skin | Limited
(