The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, males 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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Hair Boom 69" device. The submission asserts substantial equivalence to a predicate device, the "HairMax Laser 80," rather than presenting a new study with acceptance criteria and device performance. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available because the submission is based on demonstrating substantial equivalence to a predicate device, not on a new clinical study with specific acceptance criteria that the device's performance was measured against.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No new clinical test set was used for the Hair Boom 69 as part of this 510(k) submission. The device's equivalence is based on its technological characteristics and the predicate device's existing clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. No new ground truth was established for a test set for the Hair Boom 69 in this submission.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC comparative effectiveness study was not done as part of this 510(k) submission.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a hardware product (laser helmet) and does not involve an algorithm with standalone performance.

7. Type of Ground Truth Used:

Not applicable to the Hair Boom 69 itself in this submission. The "ground truth" for its efficacy relies on the prior clearance of the predicate device, HairMax Laser 80, which presumably established its efficacy through its own studies.

8. Sample Size for the Training Set:

Not applicable. No training set was used for this device as it's a hardware device demonstrating equivalence, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of the K182562 Submission for Hair Boom 69:

The document focuses on establishing substantial equivalence of the "Hair Boom 69" to the "HairMax Laser 80" (K180885). This means the Hair Boom 69 did not undergo a new clinical trial to define and meet specific acceptance criteria. Instead, its safety and effectiveness are inferred from the predicate device's prior clearance based on similar intended use and technological characteristics.

Key points from the submission regarding "performance":

No clinical performance data was produced for this submission because the Hair Boom 69 is an equivalent device in optical, electronic, and mechanical function, as well as recommended clinical treatment regime, to the predicate device.
The Hair Boom 69 was tested to internationally recognized non-clinical standards (IEC, AAMI/ANSI, ISO standards for laser safety, basic safety, EMC, home use, software, risk management, and biological evaluation). These standards demonstrate the device's safety and quality manufacturing, but do not directly assess clinical efficacy in terms of hair growth.
The submission highlights that both devices use Class IIIa/3R laser systems (by IEC standard) and have similar adverse event profiles.
The only ergonomic design distinction mentioned is that the Hair Boom 69 is a helmet design, while the HairMax Laser 80 is a cap design, which the sponsor believes does not affect therapeutic value or safety.
Both devices share the same treatment regime: 30 minutes, every other day, on non-consecutive days, or three times per week for 16 weeks.

In essence, the "study" proving the device meets acceptance criteria (in this context, substantial equivalence to the predicate) is the comparison chart and the assertion that "the Hair Boom 69, is substantially equivalent to the HairMax Laser 80 and based upon the equivalent technological designs of the compared devices." The acceptance criteria for this type of submission are legal and regulatory (meeting the requirements for substantial equivalence to a legally marketed predicate) rather than specific clinical performance metrics for the new device.

Summary

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WONTECH % Raymond Blanche Consultant NST Consultants. Inc. 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928

November 16, 2018

Re: K182562

Trade/Device Name: Hair Boom 69 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 4, 2018 Received: September 18, 2018

Dear Raymond Blanche:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Neil R.P.
Ogden
Digitally signed by Neil
R.P. Ogden
Date: 2018.11.16
14:44:27 -05'00'

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182562

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 ofl - 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)
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1ZI Prescription Use (Part 21 CFR 801 Subpart D)

D Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary –Revised 10-25-2018

WONTECH

Submitter's Contact Information

Name:	Raymond R. Blanche
Address	NST Consultants, Inc.641 Shunpike Road, Suite 311Chatham, NJ 07928
Telephone:	(973)539-7444
Facsimile:	(973)539-7445

Name of Device and Name/Address of Sponsor

Trade Name:	Hair Boom 69
Sponsor ContactInformation:	Ms. Gyuri (Erin) ParkWONTECH.64 Techno 8-ro, Yuseong-GuDaejeonRepublic of Korea 305-500

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 Devices:

Device Trade Name	Manufacturer
HairMax Laser 80 K180885	Lexington International,LLC.

Reference Devices:

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Date Prepared: September 4, 2018

Intended Use / Indications for Use

Technological Characteristics

Performance Data:

No clinical performance data was produced for this submission because the Hair Boom 69 is an equivalent device in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the HairMax Laser 80. There is one ergonomic design distinction between the two systems. The Hair Boom 69 is a substantive helmet design versus a cap design for the HairMax Laser 80.

The Hair Boom 69 was tested to internationally recognized standards, consistent with the current recommendations adopted by the FDA.

1. IEC 60825-1 Edition 2.0 2007 03 Laser Safety & Classification
1. IEC 60601-1:2005 (currently called AAMI/ANSI standard) Basic Safety and Essential Performance
1. IEC 60601-1-2 Edition 1.0. 2010 -04 EMC. This replaces Edition 3.0 2007 03
1. IEC 60601-1-11 Edition 1.0 2014 06 Home Use. This replaces Edition 2010 04
1. IEC 62304 Edition 1.1 2015 06 Software and Life Cycle Processes
1. ISO 14971 Second edition 2007 03 01 Application of Risk Management to Medical Devices
1. ISO 10993-1 2009 (R) 2013 Biological Evaluation of Medical Devices Part 1 Evaluation and Testing within a Risk Management Process. ISO 10993-10:2010/(R) 2014 -Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

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Substantial Equivalence

The Hair Boom 69 is equivalent to the device known as the HairMax Laser 80 cleared under 510(k) number, K180885. It is as safe and effective as the predicate device. Both systems, which use red light diode lasers which are 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. The sponsor believes that the difference in the physical appearance or in the method of delivering the radiant energy of the two systems is of no consequence and does not effect the therapeutic value or the safety profile.

Finally, data summarized in the 510(k) notice confirms the safety and efficacy of the Hair Boom 69 for Prescription Use, according to Part 21 CFR 801 Subpart D. 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 and the HairMax Laser 80 devices possess the same treatment regime of 30 minutes, every other day, on non-consecutive days, or three times per week for 16 weeks.

Hair Boom 69	HairMax Laser 80
LLLT Device Type	LLLT Device Type
Prescription	OTC
Intended Use - Androgenetic Alopecia	Intended Use - Androgenetic Alopecia
Contain Laser Diodes- 69 Class 3R	Contain Laser Diodes- 80 Class 3R
Helmet Design	Cap Design
Wavelength 650 +/- 5 nms.	Wavelength 650 +/- 5 nms.
Marketing Clearance -Females & Males, Prescription	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 IIa-V Hair Loss Classification	Hamilton-Norwood IIa-V Hair Loss Classification
Ludwig-Savin I - II Hair Loss Classification	Ludwig-Savin I – II Hair Loss Classification
Device Class II	Device Class II

The following Comparison Chart in support of substantial equivalence is provided:

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Conclusion

With the data presented in the Comparison Chart, the sponsor believes that this demonstrates the Hair Boom 69, is substantially equivalent to the HairMax Laser 80 and based upon the equivalent technological designs of the compared devices, the sponsor requests the FDA to clear the device via the 510(k) notice.

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.