(44 days)
Not Found
No
The description focuses on low-level laser technology and its physical characteristics, with no mention of AI or ML.
Yes
The device is intended to treat androgenetic alopecia and promote hair growth, which are therapeutic claims.
No
The device is intended to treat Androgenetic Alopecia and promote hair growth, not to diagnose the condition.
No
The device description explicitly states it is a "low-level laser device" and describes physical components like "laser diodes" configured "inside a headband" with a "rechargeable battery." This indicates a hardware component is integral to the device's function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The Laser Headband is a device that applies low-level laser light directly to the scalp. It does not analyze samples taken from the body.
- Intended Use: The intended use is to treat hair loss and promote hair growth by interacting with the scalp tissue, not by analyzing biological samples.
Therefore, based on the provided information, the Laser Headband falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Laser Headband is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.
Product codes
OAP
Device Description
Similar to the Hair Laser Helmet, the Hair Laser Headband is a low-level laser device and is intended/indicated for over- the-counter use. The device emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp at 655 +/- 5 nanometers with an individual laser output of 5mW per laser diode. The lasers are configured inside a headband, designed for hands-free operation during treatment. The laser headband is for portable use with rechargeable battery.
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 Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on the nature of modifications implemented, the Hair Laser Headband underwent bench testing and results indicate that the Hair Laser Headband shares the same output parameters and dose rate characteristics as the Hair Laser Helmet.
Design verification and design validation testing were performed according to FDA's Design control activities per 21 CFR 820.30. Additionally, Risk Management activities were performed according to ISO 14971:2012 to evaluate new risks from design changes and all residual risks were found to be acceptable.
In all instances, the Hair Laser Headband performed as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 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.
Pulsaderm LLC Gloria Avendano Regulatory Affairs Manager 12801 Commonwealth Dr. Units 2-6 Fort Myers, Florida 33913
Re: K182501
Trade/Device Name: Hair Laser Headband Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 12, 2018 Received: September 12, 2018
October 26, 2018
Dear Gloria Avendano:
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 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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Neil R Ógden -S 2018.10.26 10:23:41 -04'00' 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)
Device Name Hair Laser Headband
Indications for Use (Describe)
The Laser Headband is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of 11a to V patterns of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale 1-4, 11-1, or frontal, both with Fitzpatrick Skin Types I to IV.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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FDA 510(k) Summary of Safety and Effectiveness for The Hair Laser Headband
General Information
Submitter: Pulsaderm LLC 12801 Commonwealth Dr. Units 2-7 Fort Myers, Florida 33913
Contact Person:
Gloria Avendano Regulatory Affairs Manager Pulsaderm LLC 12801 Commonwealth Dr. Units 2-7 Fort Myers, Florida 33913 Gloria@pulsaderm.com
Summary Preparation Date:
Device
| Device Name: | Hair Laser Headband |
|---|---|
| Classification Name: | Laser Surgical Instrument, for use in General and Plastic |
| Surgery and in Dermatology | |
| Regulation Numbers: | 21 CFR 890.5550 |
| Regulatory Class: | II |
| Product Codes: | OAP |
3. Predicate Devices:
The Laser Headband is substantially equivalent to the following predicate devices;
| Device | 510(k) Number | Manufacturer |
|---|---|---|
| NutraStim Hair Laser Helmet | K160728 | Pulsaderm LLC |
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Device Description
Similar to the Hair Laser Helmet, the Hair Laser Headband is a low-level laser device and is intended/indicated for over- the-counter use. The device emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp at 655 +/- 5 nanometers with an individual laser output of 5mW per laser diode. The lasers are configured inside a headband, designed for hands-free operation during treatment. The laser headband is for portable use with rechargeable battery.
Intended Use and Indications:
The Hair Laser Headband is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.
Technological Characteristics
The Hair Laser Headband shares the exact same fundamental scientific technology characteristics to the Hair Laser Helmet. The only modifications are the following:
- Size and dimensions change
- . Reduce number of diodes
The main technological characteristics in the Hair Laser Headband remain the same, such as wavelength and output of laser diodes, treatment regiment regimen, materials, delivery method, indications for use, helmet-like design, single on/off push button, and both devices use a rechargeable battery.
The modifications mentioned above have no effect in the safety or efficacy of the Hair Laser Headband as users are instructed to move the device in three different sections of the head to achieve the same surface treatment as the Hair Laser Helmet.
Performance Data:
Similar to the Hair Laser Helmet, the Hair Laser Headband complies with the following test standards:
IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
IEC 60825-1 Safety of laser products - Part 1: Equipment classification and requirements.
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Based on the nature of modifications implemented, the Hair Laser Headband underwent bench testing and results indicate that the Hair Laser Headband shares the same output parameters and dose rate characteristics as the Hair Laser Helmet.
Design verification and design validation testing were performed according to FDA's Design control activities per 21 CFR 820.30. Additionally, Risk Management activities were performed according to ISO 14971:2012 to evaluate new risks from design changes and all residual risks were found to be acceptable.
In all instances, the Hair Laser Headband performed as intended.
Substantial Equivalence
The Hair Laser Headband shares the same technological characteristics as the Hair Laser Helmet K160728:
| Device | Hair Laser Headband | Hair Laser Helmet |
|---|---|---|
| 510 (k) Number | pending | K160728 |
| Product Code | OAP | OAP |
| Regulation | ||
| Number | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Legal | ||
| Manufacturer | Pulsaderm LLC | Pulsaderm LLC |
| Device Type | Portable headband sits on patient's head | Portable helmet sits on patient's head, |
| Indications for | ||
| Use | Indicated to treat Androgenetic Alopecia and | |
| promote hair growth in Males who have | ||
| Norwood Hamilton Classifications of IIa to V | ||
| patterns of hair loss and treat Androgenetic | ||
| Alopecia and promote hair growth in females | ||
| who have Ludwig (Savin) Scale I-4, II-1, II-2, or | ||
| frontal, both with Fitzpatrick Skin Types I to IV. | Indicated to treat Androgenetic Alopecia | |
| and promote hair growth in Males who have | ||
| Norwood Hamilton Classifications of IIa to | ||
| V patterns of hair loss and treat | ||
| Androgenetic Alopecia and promote hair | ||
| growth in females who have Ludwig | ||
| (Savin) Scale I-4, II-1, II-2, or frontal, both | ||
| with Fitzpatrick Skin Types I to IV. | ||
| Type of Use | Over the Counter | Over the Counter |
| Number of Laser | ||
| Diodes | 40 | 82 |
| Wavelength | 655 +/- 5 nanometers | 655 +/- 5 nanometers |
| Laser | ||
| Classification | Class 3R | Class 3R |
| Treatment | ||
| Protocol | 20 Minutes- 3 times a week | 20 Minutes- 3 times a week |
| Standards | ||
| Applied | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60825-1 | ||
| ISO 14971 | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60825-1 | ||
| ISO 14971 | ||
| Device Class | Class II | Class II |
| Sterilization | Basic cleaning, instructions provided. | Basic cleaning, instructions provided. |
| Common Name | Lamp, Non-Heating | Lamp, Non-Heating |
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The minor modifications in dimensions and number of diodes have no effect in the safety or efficacy of device, as confirmed with performance testing and risk analysis activities.
Conclusion:
Based upon the indications for use and data provided in this pre-market notification, all functional modes of the Hair Laser Headband have been shown to be substantially equivalent to the Hair Laser Helmet with respect to intended use, technological characteristics and safety characteristics. Pulsaderm LLC believes that no significant differences exist between the device and the predicate. Therefore, Substantial equivalency is requested.