(255 days)
Not Found
No
The device description explicitly states "The Nutra Light Blue does not use any software." and there are no mentions of AI, ML, or related concepts in the summary.
Yes.
The device is intended for the "treatment of mild to moderate inflammatory acne," which directly states a therapeutic purpose.
No
The device is described as providing light therapy for treatment of mild to moderate inflammatory acne, not for diagnosis.
No
The device description explicitly states, "The Nutra Light Blue does not use any software." It is a hardware device utilizing LEDs.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of mild to moderate inflammatory acne" by delivering LED light to the skin surface. This is a therapeutic use, not a diagnostic one.
- Device Description: The device description focuses on the physical components and how it delivers light. There is no mention of analyzing biological samples (like blood, urine, or tissue) or providing information about a patient's health status based on such analysis.
- Lack of Diagnostic Elements: IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests.
In summary, the Nutra Light Blue is a therapeutic device that uses light for treatment, not a diagnostic device that analyzes samples to provide health information.
N/A
Intended Use / Indications for Use
The Nutra Light Blue is a non-invasive LED light device is intended/indicated for over- the-counter use. The device delivers low intensity light emitting diodes (LED's) in the blue region at a wavelength of 410 +/- 5 nanometers, for the treatment of mild to moderate inflammatory acne.
Product codes
OLP
Device Description
The Nutra Light Blue Model: NL-2213, is deviccs that utilize Light Emitting Diodes to provide LED light to the body. The Nutra Light Blue is a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Blue is 410 +/- 5 at 75 mW. The Nutra Light Blue unit contains the power supplies, internal NI-MH rechargeable battery and the control unit. The enclosure and LED lens are made of medical grade biocompatility plastics via injection molding. It has the capabilities to deliver the light to the skin as the unit is moved over the skin surface. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Light Blue does not use any software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
An OTC Usability Study was conducted with the following four goals in mind 80 participants;
-
- To attract participants that represented the "intended users" of the device;
-
- To determine if consumers could correctly self-select using the packaging labeling only
-
- To test consumer knowledge of the packaging labeling and user manual and actually assembly, operate and care for the device correctly. All four goal of the study were met.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An OTC Usability Study was conducted with the following four goals in mind 80 participants;
-
- To attract participants that represented the "intended users" of the device;
-
- To determine if consumers could correctly self-select using the packaging labeling only
-
- To test consumer knowledge of the packaging labeling and user manual and actually assembly, operate and care for the device correctly. All four goal of the study were met.
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image shows the words "K132838 MAY 23 2014 nutra luxe MD NUTRA LIGHT". The words "NUTRA LIGHT" are in a larger font size than the other words. The words "nutra luxe MD" are in a smaller font size and are located above the words "NUTRA LIGHT". The date "MAY 23 2014" is above the words "nutra luxe MD".
510K Summary of Safety and Effectiveness for Nutra Light Blue
| 1. | General Information | |
|---|---|---|
| Submitter: | NutraLuxe MD, LLC | |
| 6835 International Center Blvd Suite 4-5 | ||
| Fort Myers, Florida 33912 | ||
| Contact Person: | C/O Jill Creasy | |
| RIC - Regulatory & ISO Consulting | ||
| 5575 Santa Rosa Ct. | ||
| Sparks, NV 89436 | ||
| 775-622-9591 | ||
| info@ricreg.com | ||
| Summary Preparation Date: | May 15, 2014 | |
| 2. | Device Name | |
| Device Name: | Nutra Light Blue (Model: NL-2213) | |
| Classification Name: | Laser Surgical Instrument, for use in General and Plastic | |
| Surgery and in Dermatology, | ||
| Regulation Numbers: | 21 CFR 878.4810 | |
| Regulatory Class: | II | |
| Product Codes: | OLP |
3. Predicate Device
The Nutra Light Blue is substantially equivalent to the Evis MD Platinum Blue (K082232), Tanda Skincare System (0800591) and Quasar Blue (K093963)
1
Device Description 4.
The Nutra Light Blue Model: NL-2213, is deviccs that utilize Light Emitting Diodes to provide LED light to the body. The Nutra Light Blue is a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Blue is 410 +/- 5 at 75 mW. The Nutra Light Blue unit contains the power supplies, internal NI-MH rechargeable battery and the control unit. The enclosure and LED lens are made of medical grade biocompatility plastics via injection molding. It has the capabilities to deliver the light to the skin as the unit is moved over the skin surface. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The Nutra Light Blue does not use any software.
5. Intended Use and Indications:
The Nutra Light Blue is a non-invasive LED light device is intended/indicated for over- the-counter use. The device delivers low intensity light emitting diodes (LED's) in the blue region at a wavelength of 410 +/- 5 nanometers, for the treatment of mild to moderate inflammatory acne.
Substantial Equivalency & Comparison of Technological Similarities and Differences 6.
The intended use and technological characteristics of the Nutra Light Blue are equivalent to the listed predicates.
- Has the same intended use as the predicates (i.e., Treatment of mild to moderate acne). 1.
- Has a similar output (i.e., 75 mW/cm- ) as the predicates 2.
- Utilizes a similar wavelength (i.e., 410 nm) as the predicates 3.
- Utilizes a same treatment duration (i.e., 3 minutes per target area) as the predicates 4.
- Utilizes a similar treatment regimen (i.e., 2 treatments per week for 6 weeks) 5.
Any differences between the Nutra Light Blue and the predicates device are not significant to its safety or effectiveness for its intended use.
Clinical Performance Data 7.
An OTC Usability Study was conducted with the following four goals in mind 80 participants;
-
- To attract participants that represented the "intended users" of the device;
-
- To determine if consumers could correctly self-select using the packaging labeling only
-
- To test consumer knowledge of the packaging labeling and user manual and actually assembly, operate and care for the device correctly. All four goal of the study were met.
8. Nonclinical Performance Data
The Nutra Light Blue device was tested and complies with Electrical Safety and EMC testing, which include the requirements of IEC 60601-1 "Medical Electrical Equipment Part 1 - General Requirements for Safety" IEC 60601-1-2 "Medical Electrical Equipment Part 1-2, General Requirements for Safety -Collateral Standard Electromagnetic Compatibility Requirements and Tests. IEC 60601-2-57, Medical Electrical Equip. - Part 2-57 Basic Safety and Performance of Non-Laser Light Cosmetic/Aesthetic use. IEC 62471 Photobiological Safety of lamps and lamp systems. In addition, testing and analysis have demonstrated compliance of the plastic within ISO 10993 (Biocompatibility).
9. Regulatory Requirements
NutraLuxe MD manufactures under strict quality assurance guidelines and US FDA Good Manufacturing Practice (GMP)
Nutra Luxe MD is fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations and risk analysis conforms to ISO 14971.
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Image /page/2/Picture/0 description: The image shows the logo for Nutra Luxe MD Nutra-Light. The words "nutra luxe MD" are in a smaller font size and are located above the words "NUTRA-LIGHT", which are in a larger font size. There is a flower-like symbol above the word "luxe". The logo is surrounded by some decorative lines.
10. Substantial Equivalence
Based upon an analysis of the overall performance characteristics the Nutra Light Blue device was found to have the same intended use and indication for use as the predicate devices. The device also has similar technological characteristics to its predicate devices. The minor technological differences between the Nutra Light Blue and predicate devices do not raise any issues of safety or effectiveness.
Therefore, Nutra Luxe MD, Inc. found the Nutra Light Blue device to be substantially equivalent to the legally marketed predicate devices.
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food und Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
May 23, 2014
NutraLuxe MD, LLC % Ms. Jill Creasy Regulatory & ISO Consulting 5575 Santa Rosa Court Sparks, Nevada 89436
Re: K132838
Trade/Device Name: Nutra Light Blue Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OLP Dated: May 6, 2014 Received: May 14, 2014
Dear Ms. Creasy:
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 cnacunent 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: CDRFI does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
1f 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
4
Page 2 - Ms. Jill Creasy
device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 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" (21CFR 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/Medica]Devices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K132838
Device Name Nutra Light Blue
Indications for Use (Describe)
The Nutra Light Blue is a non-invasive LED light device is indicated for over- the -counter use for the treatment of mild to moderate inflammatory acne.
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)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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