Theradome LH80 PRO

K171775 · Theradome, Inc. · OAP · Jan 9, 2018 · Physical Medicine

Device Facts

• Record ID: K171775
• Device Name: Theradome LH80 PRO
• Applicant: Theradome, Inc.
• Product Code: OAP · Physical Medicine
• Decision Date: Jan 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Theradome LH80 PRO is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.

Device Story

Theradome LH80 PRO is a wearable, one-size-fits-all helmet for low-level coherent light therapy (LLLT) to treat androgenetic alopecia. Device utilizes 80 coherent light diodes (678nm) to deliver light stimulation to the entire scalp. Operated by the patient in a home setting; hands-free design. User initiates treatment via a single button; device features an audible timer that automatically terminates the 20-minute session. Output is non-heating coherent light. Intended to promote hair growth; benefits patient by providing a convenient, automated therapeutic intervention for hair loss.

Clinical Evidence

No clinical data. Performance testing was limited to bench testing to verify design specifications, including compliance with IEC-60825-2007-03 for Class 3R laser safety (5mW maximum AEL). Usability testing was conducted to ensure comprehension of user instructions, warnings, and precautions.

Technological Characteristics

LLLT device; 80 coherent light diodes; 678nm wavelength; Class 3R laser (IEC-60825-2007-03); 5mW maximum AEL; helmet form factor; one-button operation; audible timer; 20-minute treatment cycle; standalone operation.

Indications for Use

Indicated for males (Norwood-Hamilton IIa-V) and females (Ludwig-Savin I-1 to I-4, II-1, II-2) with Androgenetic Alopecia and Fitzpatrick Skin Types I-IV to promote hair growth.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Theradome LH80 PRO (K122950)

Reference Devices

• Capillus82 (K163170)
• iHelmet (K162782)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.

January 9, 2018

Theradome Inc. Tamim Hamid President and CEO 4900 Hopyard Rd, Ste 100 Pleasanton, California 94588

Re: K171775

Trade/Device Name: Theradome LH80 PRO Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: December 6, 2017 Received: December 11, 2017

Dear Tamim Hamid:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jennifer R. Stevenson -ਟਤ 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) K171775

Device Name Theradome LH80 PRO

#### Indications for Use (Describe)

The Theradome LH80 PRO is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.

Type of Use (Select one or both, as applicable)

| <span>Foundation Use (Part 21 CFR 201.66) - Select One</span> | <span></span> |
|------------------------------------------------------------------|---------------|
| <span>Own Firm Construction (21 CFR 211.111) - Select One</span> | <span></span> |

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 5.0 Traditional 510(k) Summary

# Date Prepared: Thursday, January 4, 2018

Image /page/3/Picture/2 description: The image shows the logo for Theradome Hair Growth Treatment System. The word "theradome" is written in a combination of gray and blue colors. Above the word "theradome" are three blue curved lines, and below the word is the phrase "Hair Growth Treatment System" in blue.

| Submitter's Contact Information: | Sarah Mersereau, MBA PMP<br>Consultant, Theradome Inc.<br>4900 Hopyard Road, Suite 100<br>Pleasanton, CA 94588<br>Telephone: [phone]<br>Email: [e-mail] |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Device and Name / Address of Sponsor: | Theradome LH80 PRO<br>Theradome Inc.<br>4900 Hopyard Road, Suite 100<br>Pleasanton, CA 94588<br>Telephone: [phone]<br>Fax: [phone]<br>Establishment Registration# 274120 |
| Sponsor Contact Information: | Tamim Hamid, PhD<br>CEO, Theradome Inc.<br>4900 Hopyard Road, Suite 100<br>Pleasanton, CA 94588<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Name and Classification | Product/Trade Name: Theradome LH80 PRO<br>Common or Usual Name: Theradome LH80 PRO<br>Classification Name: Infrared lamp per 21 CFR 890.5500<br>Product Code: OAP (Coherent light, Comb, Hair)<br>Regulation Number: 21 CFR 890.5500<br>Panel: General and Plastic Surgery<br>Class: II |

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#### Predicate Devices:

| Predicate | 510(k) Number | Device Name | Manufacturer |
|------------|---------------|--------------------|---------------------------------|
| Primary | K122950 | Theradome LH80 PRO | Theradome Inc. |
| Reference | K163170 | Capillus82 | Capillus LLC |
| Additional | K162782 | iHelmet | Slinph Technologies<br>Co., Ltd |

Device Trade Name Manufacturer 510(k)

#### Device Description Summary

The Theradome LH80 PRO for men and women is a low level coherent light therapy (LLLT) device utilised to promote hair growth. The coherent lights are contained inside a lightweight, one-size fits all helmet. The Theradome LH80 PRO uses 80 coherent light diodes in the helmet to deliver coherent light stimulation to the entire scalp for hands-free operation during treatment. An audible timer automatically turns the coherent lights off after the 20 minutes treatment is completed. This coherent light helmet is not constructed to be a safety helmet.

#### Intended Use / Indications for Use

The Theradome LH80 PRO is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-2; both with Fitzpatrick Skin Types I to IV.

## Technological Characteristics

The Theradome LH80 PRO coherent light Helmet is a low level coherent light therapy (LLLT) device used to promote hair growth. The coherent lights are contained inside a lightweight onesize-fits-all helmet. The Theradome LH80 PRO utilizes 80 coherent light diodes to deliver coherent light stimulation to the entire scalp for hands-free operation during treatment. The device is onebutton operated, and has an audible timer that automatically turns the coherent lights off after the 20 minute treatment completes.

#### Performance Data

Performance testing was conducted to confirm compliance to design specifications; all functions have been verified to operate as designed. All acceptance criteria were met by the devices. The Theradome LH80 PRO conforms to the standard IEC-60825-2007-03. This IEC standard is a recognized and accepted standard by the FDA. The guidance document for this accepted standard is found in the Federal register, July 26, 2001 (volume 66, Number 144) [page 39049 39050]. This report validates for the Theradome LH80 PRO the coherent light class of 3R which establishes the AEL (accessible emission limits) as 5 milliwatts maximum. The data presented in this submission is restricted to self-selection and usability to include comprehension of user instructions, warnings, and precautions.

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#### Brief Description of NonClinical Testing

As part of establishing substantial equivalence between LH80 PRO, iHelmet, and Capillus82 devices within the LH80 PRO (K171775) 510(k) submission, the technological characteristics, such as, fluence, irradiance, treatment time, number of diodes, etc. are compared within the subject and predicate devices.

#### Brief Description of Clinical Testing

Not applicable.

#### Substantial Equivalence

Theradome LH80 PRO utilizes the same fundamental technology and comparable technological parameters as the predicates. Please see table below.

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| Theradome LH80 PRO | Theradome LH80 PRO | Capillus82 | iHelmet |
|------------------------|------------------------|------------------------|------------------------|
| | - Females only | | |
| K171775 | K122950 | K163170 | K162782 |
| LLLT Device Type | LLLT Device Type | LLLT Device Type | LLLT Device Type |
| Prescription Use/OTC | Prescription Use/OTC | Prescription Use/OTC | Prescription Use/OTC |
| Intended Use - | Intended Use - | Intended Use - | Intended Use - |
| Androgenic Alopecia | Androgenic Alopecia | Androgenic Alopecia | Androgenic Alopecia |
| Contains coherent | Contains coherent | Contains coherent | Contains coherent |
| light diodes- Class 3R | light diodes- Class 3R | light diodes- Class 3R | light diodes- Class 3R |
| Helmet/Cap Design | Helmet/Cap Design | Helmet/Cap Design | Helmet/Cap Design |
| 678nm | 678nm | 650nm | 650nm |
| Marketing clearance | Marketing clearance | Marketing clearance | Marketing clearance |
| for Males and Females | for Females | for Males and Females | for Males and Females |
| Passive Use-Hands | Passive Use-Hands | Passive Use-Hands | Passive Use-Hands |
| Free | Free | Free | Free |
| Features - One button | Features - One button | Features - One button | Features - One button |
| operation, audible | operation, audible | operation, audible | operation, audible |
| timer, status LED | timer, status LED | timer, status LED | timer, status LED |
| Treatment time- 20 | Treatment time- 20 | Treatment time- 30 | Treatment time- 20 |
| minutes | minutes | minutes | minutes |
| Irradiance = same | Irradiance = same | Irradiance = | Irradiance = |
| | | comparable | comparable |
| Fluence = same | Fluence = same | Fluence = comparable | Fluence = comparable |
| 80 coherent light | 80 coherent light | 82 Coherent light | 200 Coherent light |
| diodes | diodes | diodes | diodes |
| OAP Classification | OAP Classification | OAP Classification | OAP Classification |
| Classification Name - | Classification Name - | Classification Name - | Classification Name - |
| Infrared Lamp | Infrared Lamp | Infrared Lamp | Infrared Lamp |
| Common Usage Name | Common Usage Name | Common Usage Name | Common Usage Name |
| -Lamp, Non-Heating | -Lamp, Non-Heating | -Lamp, Non-Heating | -Lamp, Non-Heating |
| General & Plastic | General & Plastic | General & Plastic | General & Plastic |
| Surgery Committee | Surgery Committee | Surgery Committee | Surgery Committee |
| Fitzpatrick Skin | Fitzpatrick Skin | Fitzpatrick Skin | Fitzpatrick Skin |
| Phototypes - I- IV | Phototypes - I- IV | Phototypes - I- IV | Phototypes - I- IV |
| Ludwig-Savin I-II | Ludwig-Savin I-II | Ludwig-Savin I-II | Ludwig-Savin I-II |
| (females) Norwood | (females) | (females) Norwood | (females) Norwood |
| Hamilton IIA-V (males) | Hamilton IIA-V (males) | Hamilton IIA-V (males) | Hamilton IIA-V (males) |
| Device Class II | Device Class II | Device Class II | Device Class II |

# Conclusion

Based on the comparable indications for use and technological characteristics the subject device is substantially equivalent to the predicates.