(89 days)
No
The device description and performance studies focus on the laser technology and usability testing, with no mention of AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated to promote hair growth in females with androgenetic alopecia" and "in males with androgenetic alopecia," which describes its therapeutic purpose.
No
Explanation: The device is indicated to promote hair growth by using diode lasers configured within a helmet, and its description and intended use do not mention diagnosing any conditions.
No
The device description explicitly states it is a "diode laser configured within an outer helmet and protective inner liner," indicating it is a hardware device.
Based on the provided information, the Hair Boom 69 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Hair Boom 69 Function: The Hair Boom 69 is a laser device applied externally to the head to promote hair growth. It does not involve the analysis of any biological specimens.
The description clearly indicates it's a device that uses diode lasers applied to the scalp for a therapeutic purpose (promoting hair growth), not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Hair Boom 69 is indicated to promote hair growth in females withrogenetic 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.
Product codes
OAP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper 1/3 of the head
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 demonstrate that 86.66% of subjects satisfactorily passed the testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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
1
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)
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.
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 311 | |
| Chatham, 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) Park |
| WONTECH. | |
| 64 Techno 8-ro, Yuseong-Gu | |
| Daejeon | |
| Republic 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
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.
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.
-
- IEC 60825-1 Edition 2.0 2007 03 Laser Safety & Classification
-
- IEC 60601-1:2005 (currently called AAMI/ANSI standard) Basic Safety and Essential Performance
-
- IEC 60601-1-2 Edition 1.0. 2010 -04 EMC. This replaces Edition 3.0 2007 03
-
- IEC 60601-1-11 Edition 1.0 2014-06 Home Use. This replaces Edition 2010-04
-
- IEC 62304 Edition 1.1 2015 06 Software and Life Cycle Processes
-
- ISO 14971 Second edition 2007 03 01 Application of Risk Management to Medical Devices
-
- 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.