(87 days)
No
The device description and summary explicitly state that AI, DNN, or ML were not found, and the device operates as a simple laser therapy device with a timer.
Yes
The "intended use" explicitly states that it is an "over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth."
No
The device is described as a "therapeutic device intended to treat Androgenetic Alopecia and promote hair growth," not to diagnose a condition.
No
The device description explicitly states it is a "laser helmet" containing "red, visible light diode lasers" and is a "low level laser therapy (LLT) device," indicating it is a hardware device that delivers energy.
Based on the provided information, the Theradome LH40 (Theragrow) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to treat Androgenetic Alopecia and promote hair growth. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a low-level laser therapy (LLLT) device that delivers light energy to the scalp. It does not involve testing samples of human origin (like blood, urine, or tissue) outside the body, which is a key characteristic of IVDs.
- Lack of IVD-related information: The document does not mention any aspects related to in vitro testing, sample analysis, or diagnostic results.
Therefore, the Theradome LH40 is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Theradome LH40 (Theragrow) is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton 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.
Product codes
OAP
Device Description
The Theradome LH40 (Theragrow) laser helmet is a low level laser therapy (LLT) device containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles to promote hair growth via photobiostimulation of the scalp. The lasers are contained inside a lightweight, one-size-fits-all helmet. The Theradome LH40 device utilizes 40 laser diodes 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 is complete.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter (OTC) therapeutic device
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
Not Found
Summary of Performance Studies
Performance testing was not required to support a substantial equivalence determination for the Theradome LH40 device. The existing performance testing; including biocompatibility, mechanical, software, and electrical and electromagnetic compatibility (EMC), are unchanged from the predicate device. Animal testing was not required to support a substantial equivalence determination for the Theradome LH40 device. Clinical testing was not required to support a substantial equivalence determination for the Theradome LH40 device.
Key Metrics
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 the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 18, 2018
Theradome, Inc. % Jacqueline Hauge Regulatory Affairs Consultant Jacqueline A. Hauge 23300 Manning Trail N Scandia, Minnesota 55073
Re: K180460
Trade/Device Name: Theradome LH40 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: February 14, 2018 Received: February 20, 2018
Dear Jacqueline Hauge:
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
1
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.
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 mediation-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, Jennifer R. Stevenson -ਟਤੋ 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)
K180460
Device Name Theradome LH40 (Theragrow)
Indications for Use (Describe)
The Theradome LH40 (Theragrow) is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton 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) |
|---|
| ------------------------------------------------- |
| ☐ Research Use (Part 21 CFR 821 Subpart B) | ☑ Same Tier Contracting (21 CFR 821 Subpart C) |
|---|---|
| -------------------------------------------- | ------------------------------------------------ |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "theradome" in a stylized font. The first part of the word, "thera," is in gray, while the second part, "dome," is in light blue. Above the word, there are three curved lines in light blue, adding a design element to the logo.
l. SUBMITTER
| Date Prepared: | February 14, 2018 |
|---|---|
| Submitter: | Jacqueline A. Hauge |
| Regulatory Consultant | |
| Phone: 763.742.8227 | |
| Email: jacqueline.hauge@gmail.com | |
| Sponsor: | Theradome, Inc. |
| 4900 Hopyard Road, Suite 100 | |
| Pleasanton, CA 94588 | |
| Phone: 510-714-0525 | |
| Fax: 925-374-1202 | |
| Establishment Registration# 3008295459 | |
| Sponsor Contact: | Tamim Hamid, PhD, CEO |
| Phone: 510-714-0525 | |
| II. DEVICE |
Trade Name: Theradome LH40 (Theragrow) Common Name: Lamp, non-heating, for promotion of hair growth Classification Name: Infrared Lamp Product Code OAP Regulatory Class: Class II Regulation Number: 21 CFR 890.5500 Panel: General and Plastic Surgery
lll. PREDICATE DEVICES
| Primary: | K161046 Theradome LH40 Evo (Theradome, Inc.) |
|---|---|
| Additional: | K171775 Theradome LH80 Pro (Theradome, Inc.) |
| Reference: | K152473 HairMax LaserComb 41 (Lexington International, LLC.) |
IV. PURPOSE OF SUBMISSION
The purpose of this Premarket Notification is to obtain FDA clearance for the expanded indications for use statement for the Theradome LH40 device to include treatment of Androgenetic Alopecia and promotion of hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss.
DEVICE DESCRIPTION V.
The Theradome LH40 (Theragrow) laser helmet is a low level laser therapy (LLT) device containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles to promote hair growth via photobiostimulation of the scalp. The lasers are contained inside a lightweight, one-size-fits-all helmet. The Theradome LH40 device utilizes 40 laser diodes 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 is complete.
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INDICATIONS FOR USE VI.
The Theradome LH40 (Theragrow) 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 lla 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.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Low level laser therapy (LLT) is the principle technology for both the subject and predicate devices. At a high-level, the Theradome LH40 (Theragrow) device has the same technological characteristics as the predicate device, including:
- Number of Laser Diode ●
- Laser Class
- Laser Power ●
- Wavelength
- Laser Delivery Method
- Helmet Design
- Single Button Operation
- . Audible Timer
- Treatment Time and Duration ●
- Materials of Construction ●
- Risk Profile
- Battery Operation
The fundamental scientific technology of the Theradome LH40 device was not changed as part of this submission.
| Technological
Characteristic | Theradome
LH40 | Theradome
LH80 | HairMax
LaserComb 41 | Theradome
LH40 |
|------------------------------------------|--------------------------------|--------------------------------|------------------------------------------------------|--------------------------------|
| Regulatory Information | | | | |
| Manufacturer | Theradome, Inc. | Theradome, Inc. | Lexington Int'l, LLC | Theradome, Inc. |
| 510(k) Number | K161046 | K171775 | K142573 | K180460 |
| Product Code | OAP | OAP | OAP | OAP |
| Device Type | OTC Only | OTC Only | OTC Only | OTC Only |
| Technological Characteristics Comparison | | | | |
| # of Coherent Light Diodes | 40 | 80 | 41 | 40 |
| Coherent Light Class | Class 3R | Class 3R | Class 3R | Class 3R |
| Wavelength (nm) | 678 (+7) | 678 (+7) | 655 (+10) | 678 (+7) |
| Laser Power for Classification | 5mW | 5mW |