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 alopeda who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classifications of Skin Phototypes I - 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 is a 510(k) premarket notification for a medical device called "Hair Boom 69". It aims to demonstrate substantial equivalence to a previously cleared predicate device, also named "Hair Boom 69" (K182562), for Over-the-Counter (OTC) use.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Key Takeaway: The submission argues for substantial equivalence primarily based on the identity of the device itself (the new Hair Boom 69 is physically identical to the previously cleared prescription-use Hair Boom 69) and specific testing for OTC use, rather than a clinical performance study demonstrating efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the sense of predefined performance metrics (like sensitivity, specificity, or improvement in a clinical outcome) for this specific submission. Instead, the "acceptance criteria" for this 510(k) revolve around establishing substantial equivalence, particularly for an Over-the-Counter (OTC) indication.

The performance data presented is focused on demonstrating safety and usability for OTC use, given the device's technical identity with its predicate.

Criterion Type	Specific Criterion (Implied)	Reported Device Performance
Technical Equivalence	Identity in optical, electronic, and mechanical function to predicate device.	"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." (Page 4)
Safety and Effectiveness	As safe and effective as the predicate device.	"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." (Page 5) Note: No new clinical efficacy data for hair growth was collected for this submission; the efficacy is reliant on the predicate's prior clearance.
OTC Usability/Safety	Users can self-select appropriately, use the device safely, and understand hazards/precautions.	"Over-the-Counter Testing was performed for this proposed submission. 30 female and male subjects were tested for Self-Selection, Usability and Hazards & Precautions. The results of these tests are contained in Section 10, Substantial Equivalence. The results demonstrate that 86.66% of subjects satisfactorily passed the testing." (Page 4)
Compliance to Standards	Adherence to relevant international and national standards.	The device was tested to standards including IEC 60825-1 (Laser Safety), IEC 60601-1 (Basic Safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (Home Use), IEC 62304 (Software), ISO 14971 (Risk Management), and ISO 10993-1/-10 (Biocompatibility). (Page 4)

2. Sample Size for the Test Set and Data Provenance

Sample Size: 30 female and male subjects were used for Over-the-Counter (OTC) Testing.
Data Provenance: The document does not specify the country of origin for the OTC testing data. It is a prospective test, as it was "performed for this proposed submission."

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

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies assessing diagnostic accuracy, especially for image-based AI. For this submission, the "ground truth" for the OTC testing was established by observing and evaluating the subjects' performance in tasks related to "Self-Selection, Usability and Hazards & Precautions." No expert readers of medical images were involved.

4. Adjudication Method for the Test Set

The document does not describe an "adjudication method" in the context of expert review for medical decision-making. For the OTC testing, the results likely involved pass/fail criteria assessed by the researchers or observers conducting the usability study, rather than expert adjudication of conflicting interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "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." (Page 4).

This means there was no study comparing human readers' (e.g., clinicians') performance with and without AI assistance, as "Hair Boom 69" is a physical device (an infrared lamp) and not an AI algorithm assisting human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. "Hair Boom 69" is a physical device, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

For the OTC testing, the "ground truth" was established based on the performance and understanding of the subjects themselves in relation to the device's instructions for use, self-selection criteria, and safety precautions. It's direct observation and evaluation of user interaction, not clinical outcomes or expert consensus on a medical diagnosis.

For the efficacy claim (hair growth), the ground truth is implicitly tied to the previous clinical data submitted for the predicate device (K182562) for its prescription use. This current submission leverages the substantial equivalence argument to inherit the efficacy claim from the predicate.

8. The Sample Size for the Training Set

The document does not mention a "training set" for an algorithm. There is no AI component described in this device submission.

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, which features a stylized depiction of human profiles. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

July 29, 2019

Re: K191154

Trade/Device Name: Hair Boom 69 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: March 11, 2019 Received: May 1, 2019

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

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Neil R. P. Ogden, M.S. Acting Team Assistant Director Light Based Devices Team 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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Indications for Use

510(k) Number (if known)

K191154

Device Name Hair Boom 69

Indications for Use (Describe)

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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510(k) Summary WONTECH

Submitter's Contact Information

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

Name of Device and Name/Address of Sponsor

Trade Name:	Hair Boom 69
Sponsor Contact Information:	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	Hair Boom 69 (K182562)
Manufacturer	Wontech

Reference Devices:

Hairmax Lasercap 80 (K180885) (For the OTC Indication for Use) Lexington International

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March 11, 2019 Date Prepared:

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 of I – II, males who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Technological Characteristics

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.

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.

Over-the-Counter Testing was performed for this proposed submission. 30 female and male subjects were tested for Self-Selection, Usability and Hazards & Precautions. The results of these tests are contained in Section 10, Substantial Equivalence. The results demonstrate that 86.66% of subjects satisfactorily passed the testing.

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Substantial Equivalence

The Hair Boom 69 is equivalent to the device known as the Hair Boom 69 cleared under 510(k) number, K182562. 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 Over-the-Counter Use, according to Part 21 CFR 801 Subpart C. 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 use of Prescription is the same device as the Hair Boom 69 proposed for OTC use. These devices are one and the same.

Hair Boom 69 (K182562)	Hair Boom 69 (Proposed)
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- 69 Class 3R
Helmet Design	Helmet 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:

Conclusion

With the data presented in the Comparison Chart, the sponsor believes 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 Over-the-Counter Testing performed and

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submitted in this application, 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.