Laser Hair Therapy is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.

Device Description

The Laser Hair Therapy is a comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth. The device provides distributed laser to the scalp at 655+/-5nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp.

The Laser Hair Therapy is designed as handheld product, and it consists of the power supply (adaptor and USB cable) and the control unit (RECREO device), as well as it is powered by the built-in rechargeable lithium battery. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 8 minutes treatment is completed.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "Laser Hair Therapy" (Model: Recreo 200). This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance criteria through a clinical study with detailed statistical outcomes.

Therefore, the text does not contain the specific information required to complete all sections of your request. It primarily outlines the technical characteristics and safety testing performed to show equivalence.

However, I can extract the available information:

1. A table of acceptance criteria and the reported device performance

Based on the document, direct performance acceptance criteria (e.g., a specific percentage increase in hair count) are not stated for the subject device. Instead, the performance data provided focuses on safety and biological compatibility, asserting that these aspects are similar to the predicate devices.

Acceptance Criterion (implicitly by proxy of predicate)	Reported Device Performance (Subject Device)
Biocompatibility (Cytotoxicity)	Passed ISO 10993-5:2009/(R)2014
Biocompatibility (Irritation & Skin Sensitization)	Passed ISO 10993-10:2010
Electrical Safety	Passed IEC 60601-1
Home Healthcare Electrical Safety	Passed IEC 60601-1-11
EMC Safety	Passed IEC 60601-1-2
Laser System Classification	Certified to Class 3R (per IEC 60825-1)
Charger Safety	Conforms to IEC 60950
Built-in Battery Safety	Conforms to IEC 62133

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail a "test set" in the context of a clinical performance study with human subjects. The performance data presented are for regulatory compliance tests (biocompatibility, electrical safety, EMC). These tests typically involve material samples or device units, not human subjects in a clinical trial. Therefore, information on sample size, country of origin, or retrospective/prospective nature for a clinical test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The "ground truth" concept usually refers to clinical outcomes established by experts for a diagnostic or predictive device. This device is a therapeutic device, and the provided data focuses on safety and technical compliance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided, as there is no described clinical "test set" and associated adjudication process.

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

An MRMC comparative effectiveness study is not mentioned in the document. This type of study is relevant for diagnostic devices that involve human interpretation assisted by AI. The Laser Hair Therapy device is a standalone therapeutic device, not an AI-assisted diagnostic tool.

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

The document describes the "Laser Hair Therapy" device as a standalone therapeutic device designed to promote hair growth. The performance data provided are for this device itself (e.g., its electrical safety, biocompatibility, laser class), rather than an algorithm. Therefore, yes, its standalone (device only) performance with respect to safety and technical specifications was evaluated. However, no standalone clinical efficacy study (e.g., showing a quantified increase in hair growth) is presented in this 510(k) summary, as it relies on substantial equivalence to predicates that previously established such efficacy.

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

For the technical and biocompatibility performance data, the "ground truth" is defined by the specific international standards (e.g., ISO 10993-5, IEC 60601-1). Passing these standards is considered the "ground truth" for compliance. For the device's efficacy in promoting hair growth, this 510(k) summary relies on the established efficacy of its predicate devices, for which the ground truth would have been clinical outcomes data (e.g., hair count measurements, photographic assessment, patient self-assessment) from their own clinical trials. This document does not present new clinical efficacy data for the subject device.

8. The sample size for the training set

The document does not describe a "training set" as it is not an AI/machine learning device requiring a dataset for model training.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned for this device.

Summary

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OMM Imports, Inc. D/B/A Zero Gravity % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg. 1, Southward Ruifeng Business Center Guimiao Road Shenzhen, 518000 China

January 16, 2019

Re: K183329

Trade/Device Name: Laser Hair Therapy Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: November 2, 2018 Received: November 30, 2018

Dear Rain Yip:

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

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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 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 (OS) 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.

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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) K183329

Device Name Laser Hair Therapy /(Model: Recreo 200)

Indications for Use (Describe)

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

"510(k) Summary" as required by 21 CFR Part 807.92.

Date: 2018-11-02

I. Submitter

OMM IMPORTS INC DBA ZERO GRAVITY 1945 S OCEAN DR APT 509 HALLANDALE BEACH BLVD FLORIDA 33009, USA

Tel.: 1 786 712 5873 Tax: 1 305 971 2199

Moti Shenfarber (CEO) Tel: 1 786 712 5873 Email: motinord@hotmail.com

II. Device

Type of 510(k): Traditional Common Name: Lamp, non-heating, for promotion of hair growth Trade Name: Laser Hair Therapy Classification Name: Infrared lamp per 21 CFR 890.5500 Review Panel: General & Plastic Surgery Regulatory Class: II Product Code: OAP Regulation Number: 21 CFR 890.5500

III. Predicate Device

Predicate device

Applicant	Predicate Device	510(k) Number	Approval Date
LexingtonInternational, LLC	HairMax LaserComb41	K142573	Dec.1, 2014
NutraLuxe MD, LLC	Nutra Stim Hair Laser CombModel NSL-6319	K141596	Jan.8, 2015
NutraLuxe MD, LLC9	Nutra Stim Hair Laser CombModel NSL-6318	K141588	Jan.8, 2015

Reference device: None

IV. Device Description

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V. Indications for Use

VI. Comparison of Technological Characteristics With the Predicate Device

The subject device Laser Hair Therapy is substantially equivalent to the predicated device based on intended use, design, specifications and performance. The subject device raises no safety or efficacy concerns when compared to the predicate devices.

Information for predicate device was obtained from publicly available sources, including the 510(k) Summary and device instruction manual. A technical comparison to the predicate is provided below:

Comparison	Subject	Predicate	Predicate	Predicated	OAP Devices
Elements	Device	Device 1	Device 2	Device 3	(General)
K Number	Pending	K142573	K141596	K141588	/
Product Code	OAP	OAP	OAP	OAP	OAP
Classification	Class II	Class II	Class II	Class II	Class II
Location forUse	OTC	OTC	OTC	OTC	OTC or Rx orboth
Intended Use	Androgenicalopecia	AndrogeneticAlopecia	AndrogeneticAlopecia	AndrogeneticAlopecia	AndrogeneticAlopecia
Type of Laser	Visible redlight-emittingdiodes	Visible redlight-emittingdiodes	Visible redlight-emittingdiodes	Visible redlight-emittingdiodes	Visible redlight-emittingdiodes
Light Class	Class 3R	Class 3R	Class 3R	Class 3R	Class 3R
Amount ofLaser Diodes	12	41	12	12	Ranges from1 to 352
Energy of PerLaser Diode	<5mW	<5mW	<5mW	<5mW	Ranges (each)from less than5mW
Wavelength	655+/-5	655+/-10	655+/-10	655+/-10	Range from
ComparisonElements(nm)	SubjectDevice	PredicateDevice 1	PredicateDevice 2	PredicatedDevice 3	OAP Devices(General)
TreatmentTime	8 minutes pertreatment3 times perweek (everyother day)	30seconds ateach of 6positions onthe scalp3-4times/week(every otherday)	8 minutes pertreatment3 times perweek (everyother day)	8 minutes pertreatment3 times perweek (everyother day)	Frequency:every otherdayThe specifictreatmenttime dependson the productdesign.(Indefinite)
ApplicablePeople	Norwood-HamiltonIIa~V (males)Ludwig-SavinI-4, II-1, II-2,or frontal(females)	Norwood-HamiltonIIa~V(males)Ludwig-Savin I-4, II-1, II-2, orfrontal(females)	Norwood-HamiltonIIa~V(males)	Ludwig-Savin I-4, II-1, II-2, orfrontal(females)	Norwood-HamiltonIIa~V (males)Ludwig-SavinI-II, or frontal(females)Or bothgenders
ApplicableSkin	FitzpatrickSkinPhototypes I-IV	FitzpatrickSkinPhototypes I-IV	FitzpatrickSkinPhototypes I-IV	FitzpatrickSkinPhototypes I-IV	FitzpatrickSkinPhototypes I-IV
AppearanceDesign	Comb	Band	Comb	Comb	Helmet/Cap,Comb, Brushor Panel andother designs
SafetyFeatures	Compliedwith:IEC60601-1-2IEC60601-1IEC60601-1-11IEC60825-1	Compliedwith:IEC60601-1-2IEC60601-1IEC60825-1	Compliedwith:IEC60601-1-2IEC60601-1IEC60825-1	Compliedwith:IEC60601-1-2IEC60601-1IEC60825-1	(General)CompliedwithIEC60601-1,IEC60601-1-2.
BiologicalFeatures	Compliedwith:ISO10993-5ISO10993-10	Unknown	Compliedwith:ISO10993-5ISO10993-10	Compliedwith:ISO10993-5ISO10993-10	All materialsof patient-contactingcomponentsshouldcomply withtherequirements
ComparisonElements	SubjectDevice	PredicateDevice 1	PredicateDevice 2	PredicatedDevice 3	OAP Devices(General)
					of ISO10993-1, andat leastcomply withISO 10993-5and ISO10993-10.

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The more details please refer to the Substantial Equivalence Discussion section in this submission.

VII.Performance Data

The following performance data were provided in support of the substantial equivalence determination.

1) Biocomnatibility Testing

The biocompatibility evaluation for the body-contacting components of the Laser Hair Therapy was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The battery of testing was performed to, and passed, including:

ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Par t 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization

2) Electrical and EMC Safety

Electrical safety and EMC safety testing was performed to, and passed, the following standards:

IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11 Medical electrical equipment -Part 1-11: General requirements for basic safety and essential performance -Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility -Requirements and tests

In addition, testing to IEC 60825-1 certifies the laser system to classification 3R, which is the same as the predicate devices. And the charger conforms to IEC 60950 and the built-in battery to IEC 62133.

Summarv

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Based on the above performance as documented in this application, Laser Hair Therapy was found to have a safety and effectiveness profile that is similar to the predicate devices.

VIII. Conclusions

OMM IMPORTS, INC. D/B/A ZERO GRAVITY found the Laser Hair Therapy is to be substantially equivalent to the legally marketed predicate devices.

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.