The Theradome Laser Helmet LH80 PRO is a prescription use therapeutic device indicated to promote hair growth in females, with androgenic alopedia, having Ludwig and Savin Hair Loss Scale classification I-II and Fitzpatrick Skin-Types I to IV.

Device Description

The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLT) device used to promote hair growth via photobiostimulation. The lasers are contained inside a lightweight, one-size fits all helmet. The LH80 PRO utilizes laser diodes in the heimet to deliver laser stimulation to the entire scalp for hands-free operation during treatment. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 20 minute treatment completes.

AI/ML Overview

The provided text is a 510(k) summary for the Theradome Laser Helmet LH80 PRO. It describes the device, its intended use, indications for use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, especially in terms of clinical performance or a multi-reader multi-case study.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

Type of Device: The Theradome Laser Helmet LH80 PRO is a low-level laser therapy (LLT) device intended to promote hair growth. This type of device typically relies on clinical studies to demonstrate efficacy, but this document does not present such a study.
Focus of the Submission: The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (RF Midwest LLC MEP-90 Hair Growth Stimulation System K091496) based on technological characteristics, intended use, and indications for use.
"Performance Characteristics" Section: This section mentions "Testing to IEC 60601-1 and 60601-1-2 confirm the device's safety and electrical compatibility" and "Testing to IEC 60825-1 certifies the laser system to classification 3R, same as predicate device." It also states, "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed." These are safety and engineering performance tests, not clinical efficacy studies with specific acceptance criteria as you've outlined.

Given the limitations of the provided text, I can only address the questions where information is explicitly available or directly inferred.

Acceptance Criteria and Study for Theradome Laser Helmet LH80 PRO

The provided 510(k) summary does not disclose specific clinical acceptance criteria for hair growth efficacy or a study proving those criteria. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through safety, electrical compatibility, and laser classification testing, rather than an independent clinical efficacy trial with predefined performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric	Acceptance Criterion	Reported Device Performance
Clinical Efficacy	(Not Specified)	(Not Specified)	(Not specified in this document)
Safety (Electrical)	Adherence to IEC Standard	IEC 60601-1	Confirmed to comply
Safety (Electromagnetic Compatibility)	Adherence to IEC Standard	IEC 60601-1-2	Confirmed to comply
Safety (Laser Classification)	Adherence to IEC Standard	IEC 60825-1 Classification 3R	Certified to Classification 3R (same as predicate)
Design Specifications	Functional Operation	All functions operate as designed	Confirmed to comply

Note: The 510(k) summary explicitly states "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed." This refers to engineering and functional performance, not clinical outcome performance.

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

Sample Size for Test Set: Not applicable / Not mentioned for clinical efficacy. The performance tests mentioned (IEC standards, design specifications) are typically conducted on a limited number of device units for engineering verification, not a clinical "test set" in the context of patient data.
Data Provenance: Not applicable for clinical data. The mentioned tests are engineering/safety in nature and would be conducted in a lab environment.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable. The document does not describe a clinical study requiring expert assessment for ground truth.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The document does not describe a clinical study or expert review process that would require an adjudication method.

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

Was an MRMC study done? No, an MRMC study was not described or conducted, as this device does not involve image interpretation or diagnostic performance that would necessitate such a study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Was a standalone study done? Not applicable. This device is a therapeutic (LLT) device, not an AI algorithm. Its performance is directly tied to its physical operation and biological effect, not an algorithmic interpretation task.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable for clinical efficacy. For the safety and performance tests mentioned (IEC standards, design specifications), the "ground truth" would be the engineering specifications and compliance requirements of the respective standards.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The device does not involve machine learning or AI that would require a training set.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary

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K1/3097
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Section 5

510(k) Summary

This 510k summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Manufacturer

Theradome Inc. Address: 4900 Hopyard Road, Suite 100 Pleasanton, CA 94588 Telephone: 510-714-0525 Fax: 925-374-1202

Official Correspondents

Mr. Larry Petersen Requiatory Consultant to Theradome 1001 Bear Island Road, Suite 139 Summerville, SC 29483 Telephone: 303-489-2500 Fax: 925-374-1202 Email: LarryPetersen7@gmail.com

Ms. Parul Chansoria Telephone: 650-796-5878 Email: parul.bme@gmail.com

Date of Submission: October 3, 2011

Device Name and Classification

Product Name:

Product Code: Requiation Number: Panel: Class: Substantial Equivalence claimed to: LH80 PRO Laser Helmet Infrared lamp per 21 CFR 890.5500 OAP 21 CFR 890.5500 General and Plastic Surgery II RF Midwest LLC MEP-90 Hair Growth Stimulation System (K091496)

Device Description

Theradome

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ı heradome Inc. Laser Helmet LH80 PRO

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Intended use

The Theradome Laser Helmet LH80 PRO is intended to treat androgenic alopecia by promoting hair growth.

Indications for Use

Technological Characteristics

The LH80 PRO delivers visible red low-level laser radiant energy to the LH80 PRO utilizes laser diodes to deliver laser stimulation to the entire scalp for hands-free operation during treatment.

Performance Characteristics

Testing to IEC 60601-1 and 60601-1-2 confirm the device's safety and electrical compatibility. Testing to IEC 60825-1 certifies the laser system to classification 3R, same as predicate device.

Nonclinical Testing

Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed.

Substantial Equivalence

Theradome wishes to use the following device as predicate:

RF Midwest LLC MEP-90 Hair Growth Stimulation System (K091496)

The LH80 PRO has the same intended use as the predicate device: treat androgenic alopedia hair growth.

The LH80 PRO has the same indications for use as the predicate device: prescription use device to promote hair growth in females, with androgenic alopedia; having Ludwig and Savin Hair Loss Scale classification I-II and Fitzpatrick Skin-Types I to IV.

The MEP-90 and the LH80 PRO both deliver treatment to the entire scalp for hands-free operation during treatment, and have the same treatment schedule.

For those reasons, the Theradome Laser Helmet LH80 PRO satisfies FDA's substantial equivalence with respect to both intended use and technological characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Theradome. Inc. % Mr. Larry Petersen Regulatory Affairs 1001 Bear Island Road, Suite 136 Summerville, South Carolina 29483

MAR - 2 2012

Re: K113097

Trade/Device Name: Theradome Laser Helmet LH80 PRO Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: NHN, OAP Dated: February 12, 2012 Received: March 1, 2012

Dear Mr. Petersen:

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

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Page 2 - Mr. Larry Petersen

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Erind Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K113097

Section 4 Indications for Use Statement

Device Name: Theradome Laser Helmet LH80 PRO

Indications for Use:

The Theradome Laser Helmet LH80 PRO is a prescription use therapeutic device indicated to promote hair growth in females, with androgenic alopecia, having Ludwig and Savin Hair Loss Scale classification I-II and Fitzpatrick Skin-Types I to IV.

Prescription Use __ X_ (Part 21 CFR 801 Subpart D) .

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden Surmkn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113097

Theradome

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.