NutraStim Hair Laser Helmet 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.

Device Description

NutraStim Hair Laser Helmet 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 timed treatments of distributed laser light to 100% of the scalp at 650 +/- 5 nanometers. The lasers are configured inside a helmet, designed for hands-free operation during treatment. The helmet is for portable use with rechargeable battery and adapter.

AI/ML Overview

The provided document describes the NutraStim Hair Laser Helmet, a low-level laser device intended to treat Androgenetic Alopecia and promote hair growth. The device is being submitted for 510(k) clearance, asserting substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of pass/fail metrics with specified thresholds for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and safety standards.

However, we can infer some key performance and safety characteristics against which the device was evaluated, and its reported performance:

Acceptance Criterion (Inferred from Substantial Equivalence and Safety Standards)	Reported Device Performance
Intended Use: Treat Androgenetic Alopecia and promote hair growth for specified male (Norwood Hamilton IIa-V) and female (Ludwig (Savin) I-4, II-1, II-2, or frontal) patterns, with Fitzpatrick Skin Types I-IV.	The NutraStim Hair Laser Helmet has the same intended use as predicate devices. Specifically, it aligns with K142573 (Hairmax 82) and K132646 (Sunetics Clinical Laser "G") regarding male and female indications and Fitzpatrick skin types.
Technological Characteristics: Wavelength, output power, energy type, laser field, treatment areas, energy delivery.	Wavelength: 650 +/- 5 nm (same as predicates) Output (Per diode): 5 mW (same as predicates) Laser Classification: Class 3R (same as predicates) Number of Laser Diodes: 82 (similar to 80-107 diodes in predicates/references) Treatment Protocol: 20 Minutes - 3 times a week (similar to predicates/references, which range from 90 seconds to 30 minutes, 3 times a week). The device provides timed treatments to 100% of the scalp.
Safety and EMC Requirements: Compliance with relevant international standards.	Electrical Safety: IEC 60601-1 (confirmed compliance) Electromagnetic Compatibility (EMC): IEC 60601-1-2 (confirmed compliance) Home Healthcare Electrical Equipment: IEC 60601-1-11 (confirmed compliance) Laser Safety: IEC 60825-1 (certified to Class 3R, same as predicates) Risk Management: ISO 14971 (applied)
Lay User and Self-Selection Ability: Lay users can understand labeling and instructions to properly self-select and use the device.	A lay-user study and self-selection study demonstrated that the vast majority of lay users could properly self-select themselves using box labeling and correctly use the device by reading user manual instructions without assistance.

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

The document mentions a "lay-user study and self-selection study" but does not specify the sample size used for this test set.

The data provenance is not explicitly stated in terms of country of origin. The study was conducted with "Institutional Review Board (IRB) approval and oversight," which typically implies prospective data collection, but this is not explicitly confirmed as "prospective" or "retrospective" in the text. Given the nature of a "lay-user study and self-selection study" for device usability, it's highly probable it was a prospective study where participants interacted with the device and its instructions in a controlled setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the lay-user and self-selection study, the concept of "ground truth" as it relates to expert medical diagnosis or outcome (e.g., hair growth assessment by radiologists) is not applicable here. The "ground truth" for this usability study would be the observable ability of lay users to correctly understand instructions and self-select.

There is no mention of experts being used to establish a medical or diagnostic ground truth for the device's efficacy. The study focused on usability and understanding of instructions.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method for the lay-user and self-selection study. Adjudication, such as 2+1 or 3+1, is typically used for ambiguous or complex diagnostic assessments, which is not the nature of this usability study. The determination of whether a user "successfully follow[ed] the instructions" or "properly self-select[ed] themselves" likely came from direct observation and analysis of their actions and responses during the study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a direct-to-consumer medical device (infrared lamp/laser for hair growth) and does not involve human readers interpreting images or data, nor does it involve AI assistance in the way a diagnostic AI would. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is a physical laser helmet and does not involve an algorithm or AI in the traditional sense. Its performance is inherent in its physical parameters (wavelength, power, treatment protocol) and its interaction with the human scalp. Therefore, a "standalone algorithm-only" performance study is not applicable. The "standalone" performance would be its direct physical output characteristics, which were tested against engineering standards (e.g., IEC 60825-1 for laser classification, output per diode).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the lay-user and self-selection study, the ground truth was based on the observable actions and stated understanding of the lay users regarding the product labeling and user manual. It's an assessment of user comprehension and usability, rather than a clinical ground truth for hair growth outcomes.

The broader "performance data" supporting substantial equivalence relies on:

Engineering and Safety Standards Compliance: Confirmed by testing to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60825-1, and ISO 14971.
Comparison to Predicate Device Specifications: Wavelength, output, laser classification, number of diodes, treatment protocol, etc., are directly compared to those of legally marketed predicate devices, implying that the established performance and safety profiles of these predicates serve as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

This document describes a premarket notification for a medical device that does not use machine learning or AI algorithms in its core functionality. Therefore, the concept of a "training set" for an algorithm is not applicable. The data presented supports its safety and technological equivalence, not the training of an AI model.

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

As there is no training set for an AI algorithm, this question is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

September 16, 2016

Nutra Luxe MD LLC Ms. Gloria Avendano Regulatory Affairs Manager 12801 Commonwealth Drive, Unit 2-6 Fort Myers, Florida 33976

Re: K160728

Trade/Device Name: Nutrastim Hair Laser Helmet Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: August 18, 2016 Received: August 18, 2016

Dear Ms. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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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 Parts 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Christopher J. Ronk -S

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) K160728

Device Name NutraStim Hair Laser Helmet

Indications for Use (Describe)

NutraStim Hair Laser Helmet is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of 11a to V patters of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale 1-4. 11-1, 11-2, 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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510 (k) Summary NutraStim Hair Laser Helmet

1. General Information

Submitter:	NutraLuxe MD, LLC
Address:	12801 Commonwealth Dr. Unit 2Fort Myers, FL 33913
Contact Person:	Gloria AvendanoRegulatory Affairs Manager
Telephone:	239-208-7541
E-mail:	Gloria@nutraluxemd.com
Summary Preparation Date:
2. Device
Device Name:	NutraStim Hair Laser Helmet
Common or usual name:	Lamp, non-heating, for promotion of hair grov

Classification Name: Classification Code:

th Infrared lamp per 21 CFR 890.5500 OAP (Laser, comb, hair)

3. Predicate Devices:

NutraStim Hair Laser Helmet is substantially equivalent to the following predicate devices;

Device	510(k) Number	Manufacturer
Sunetics Clinical Laser “G” or“W2326”	K132646	Sunetics International
Hairmax Laser Comb 82	K142573	Lexington International

Reference devices:

Device	510(k) Number	Manufacturer
LH80 Pro Laser Helmet	K122950	Theradome Inc.
MEP-90 Hair GrowthStimulation System	K091496	Midwest RF LLC
Capillus 82	K151516	Capillus LLC

4. Intended Use/Indications for Use:

NutraStim Hair Laser Helmet 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.

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5. Technological Characteristics:

Performance Data 6.

Testing to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11confirms the device adherence to safety and EMC requirements. Testing to IEC 60825-1 certifies the laser system to classification 3R, same as predicate and referenced devices.

Lay user and Self-selection studies

A lay-user study and self-selection study was conducted with Institutional Review Board (IRB) approval and oversight to determine if lay users could read the product labeling and then self-assess if the laser helmet would be beneficial for them to use. Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended. The performance data supplied in this 510(k) demonstrated that the vast majority of lay users were able to properly self-select themselves using the box labeling and lay users were able to properly use the device by reading instructions in the user manual without any assistance.

In summary, the conclusion was that an average lay user can read and comprehend correctly the user manual and package labeling.

7. Nonclinical Performance Data:

Performance testing was conducted and confirm compliance to design specifications; similar wavelength, output power, energy type, laser field, treatment areas and energy delivery as predicate and referenced devices.

8. Substantial equivalence

NutraStim Hair Laser Helmet is substantially equivalent to other hair laser therapy devices currently in commercial distribution. NutraStim Hair Laser Helmet has the same intended use as the predicate devices: Treat androgenetic alopecia with red low level laser light classification 3 R. NutraStim Hair Laser Helmet delivers treatment to the entire scalp for hands-free operation during treatment and has same treatment schedule as the predicate and referenced devices. NutraStim Hair Laser Helmet shares the same indication for treating both male and female as K142573 (Hairmax 82) and K132646 (Sunetics Clinical Laser "G"). NutraStim Hair Laser Helmet is as safe and (commensurate to number of diodes) effective as its predicate and referenced devices. NutraStim Hair Laser Helmet has 650 +/- 5nm wavelength and similar output to the treatment area as the predicate and referenced devices. Thus, NutraStim Hair Laser Helmet is substantially equivalent to legally marketed medical devices.

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Comparison Table

ComparativeItem	NutraStim HairLaser Helmet	Sunetics ClinicalLaser "G"	Capillus 82	Hairmax 82	LH80 PRO	MEP 90
510 (k)Number	K160728	K132646	K151516	K142573	K122950	K091496
Product Code	OAP	OAP	OAP	OAP	OAP	OAP
RegulationNumber	21 CFR 890.5500	21 CFR 890.5500	21 CFR 890.5500	21 CFR 890.5500	21 CFR 890.5500	21 CFR 890.5500
Device Type	Portable helmet, sitson patient's head,spherical laser helmet.	Free Standing, movablelaser helmet, sphericallaser helmet	Portable helmet,sits on patient'shead, sphericallaser helmet.	Portable helmet, sits onpatient's head, sphericallaser helmet.	Portable helmet, sitson patient's head,spherical laser helmet.	Free Standing, movablelaser helmet, sphericallaser helmet
Indicationsfor Use	Indicated to treatAndrogeneticAlopecia and promotehair growth in Maleswho have NorwoodHamiltonClassifications of IIato V patterns of hairloss and treatAndrogeneticAlopecia and promotehair growth in femaleswho have Ludwig(Savin) Scale I-4, II-1,II-2, or frontal, bothwith Fitzpatrick SkinTypes I to IV.	Indicated to treatAndrogenetic Alopeciaand promote hairgrowth in males whohave NorwoodHamiltonClassifications of IIa toV and Fitzpatrick SkinTypes I to IV and alsoin Females who haveLudwig (Savin) I-4, II-1, II-2, or frontalpatterns of hair loss andFitzpatrick Skin TypesI to IV.	Indicated topromote hairgrowth in femaleswho haveandrogeneticalopecia andLudwig-SavinClassifications ofI-11; and withFitzpatrickClassifications ofSkin Phototypes Ito IV.	Indicated to treatAndrogenetic Alopeciaand promote hair growthin Males who haveNorwood HamiltonClassifications of IIa toV patterns of hair lossand treat AndrogeneticAlopecia and promotehair growth in femaleswho have Ludwig(Savin) Scale I-4, II-1,II-2, or frontal, both withFitzpatrick Skin Types Ito IV.	Intended to treatAndrogeneticAlopecia to promotehair growth in femaleswith female patternhair loss (FPHL) onthe Ludwig and SavinHair Loss scale I-II,Fitzpatrick Skin TypesI to IV.	Intended for the treatmentof alopecia in females bypromoting hair growth offemales with androgeneticalopecia who haveLudwig and Savin HairLoss Scale classificationsof I to II and who havebeen determined to haveFitzpatrick Skin Typing ofI to IV.
Number ofLaser Diodes	82	107	82	82	80	82
Wavelength(nanometer)	650 +/- 5	650 +/- 5	650 +/- 5	650 +/- 5	678	650 +/- 5
Output (Perdiode)	5 mW	5 mW	5 mW	5 mW	5 mW	5 mW
LaserClassification	Class 3R	Class 3R	Class 3R	Class 3R	Class 3R	Class 3R
TreatmentProtocol	20 Minutes- 3 times aweek	20 minutes- 3 times aweek	30 minutes- 3times a week	90 seconds- 3 times aweek	20 minutes- 3 times aweek	20 minutes- 3 times aweek
StandardsApplied	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60825-1ISO 14971	IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60825-1	IEC 60825-1ISO 14971	IEC 60825-1	IEC 60601-1IEC 60601-1-2IEC 60825-1	IEC 60601-1IEC 60601-1-2IEC 60825-1
Device Class	Class II	Class II	Class II	Class II	Class II	Class II
Accessories	Medical Grade PowerCord	Medical Grade PowerCord	Medical GradePower Cord	Medical Grade PowerCord	Medical Grade PowerCord	Medical Grade PowerCord
CommonName	Lamp, Non-Heating	Lamp, Non-Heating	Lamp, Non-Heating	Lamp, Non-Heating	Lamp, Non-Heating	Lamp, Non-Heating

9. Conclusion:

Based upon the indications for use and data provided in this pre-market notification, all functional modes of the NutraStim Hair Laser Helmet have been shown to be substantially equivalent to current marketed predicate and referenced devices with respect to intended use, technological characteristics and safety characteristics. NutraLuxe MD believes that no significant differences exist between the device and the predicates. Therefore, Substantial equivalency is requested.

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.