(47 days)
None
No
The device description outlines a simple laser therapy device with a timer and a single button operation. There is no mention of any computational processing, data analysis, or adaptive features that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device's intended use is to "promote hair growth in males with androgenic alopecia" and "females with androgenic alopecia," which are medical conditions, and it uses "low level laser therapy (LLLT)" for this purpose, indicating a therapeutic function.
No
The device is described as a low-level laser therapy (LLLT) device intended to promote hair growth, not to diagnose a condition. Its function is therapeutic, not diagnostic.
No
The device description explicitly details hardware components such as a comb-shaped device, power supply, control unit, built-in rechargeable battery, and laser emitters.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Laser Hair Therapy device is a low-level laser therapy (LLLT) device that applies light directly to the scalp to promote hair growth. It does not involve the collection or analysis of any biological specimens.
- Intended Use: The intended use is to promote hair growth in individuals with androgenic alopecia, which is a therapeutic application, not a diagnostic one.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OAP
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.
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
Not Found
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)
The following performance data were provided in support of the substantial equivalence determination.
- 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
- 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.
Summary
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
None
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 for 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
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.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature includes the name "Neil R Ogden -S" on the left side of the image. On the right side, it states "Digitally signed by Neil R Ogden -S" with the date "2019.01.16" and time "13:45:29-05'00'".
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) K183329
Device Name Laser Hair Therapy /(Model: Recreo 200)
Indications for Use (Describe)
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.
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 |
|---|---|---|---|
| Lexington | |||
| International, LLC | HairMax LaserComb41 | K142573 | Dec.1, 2014 |
| NutraLuxe MD, LLC | Nutra Stim Hair Laser Comb | ||
| Model NSL-6319 | K141596 | Jan.8, 2015 | |
| NutraLuxe MD, LLC9 | Nutra Stim Hair Laser Comb | ||
| Model NSL-6318 | K141588 | Jan.8, 2015 |
- Reference device: None
IV. Device Description
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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.
V. Indications for Use
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.
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 for | |||||
| Use | OTC | OTC | OTC | OTC | OTC or Rx or |
| both | |||||
| Intended Use | Androgenic | ||||
| alopecia | Androgenetic | ||||
| Alopecia | Androgenetic | ||||
| Alopecia | Androgenetic | ||||
| Alopecia | Androgenetic | ||||
| Alopecia | |||||
| Type of Laser | Visible red | ||||
| light-emitting | |||||
| diodes | Visible red | ||||
| light-emitting | |||||
| diodes | Visible red | ||||
| light-emitting | |||||
| diodes | Visible red | ||||
| light-emitting | |||||
| diodes | Visible red | ||||
| light-emitting | |||||
| diodes | |||||
| Light Class | Class 3R | Class 3R | Class 3R | Class 3R | Class 3R |
| Amount of | |||||
| Laser Diodes | 12 | 41 | 12 | 12 | Ranges from |
| 1 to 352 | |||||
| Energy of Per | |||||
| Laser Diode | 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.