Nutra Light Advanced is intended/indicated for over the counter use for the treatment of mild to moderate acne and for the treatment of periorbital wrinkles and rythides.

Device Description

Nutra Light Advanced is a visible light and/or heat source with high spectral purity. The device is made of Lustran ABS 348 with clear cover lenses covering the LED light sources. The device has two exchangeable heads; with one head emitting narrow band blue light at 410mm for the treatment of mild to moderate acne vulgaris, the other head emits red light at 650mm for the treatment of periorbital wrinkles and rhytides. The device consists of a basic-hand-held, battery operated control unit and two optional (Blue and Red LED) interchangeable heads, which allows the operator to select either the blue or red operation. The STOP button directly on the unit allows the user to immediately remove all power to the unit. The device does not allow the operator to select the red and blue light simultaneously.

AI/ML Overview

The provided text is a 510(k) summary for the Nutra Light Advanced device, focusing on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics of the device itself.

Therefore, many of the requested points cannot be answered from the provided document as it does not describe a clinical study in the way typically required for a novel device proving its efficacy against acceptance criteria. Instead, it relies on demonstrating similar technical characteristics to already approved devices.

Here's a breakdown of what can be extracted and what cannot:

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

This information is not provided in the document. The document states that the device has been tested and found in compliance with performance standards (e.g., IEC 60601-1, EMC 60601-1-2, IEC 60601-2-57, ISO 10993-5, ISO 10993-10) but does not list specific acceptance criteria (e.g., a certain percentage reduction in acne lesions) or the device's measured performance against such criteria. The basis for approval is substantial equivalence to predicate devices, implying their performance is accepted.

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

This information is not provided. As no clinical study is described, there's no test set in the context of device efficacy. The "tests" mentioned are nonclinical performance data related to electrical safety, EMC, and biocompatibility, not clinical outcomes.

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 provided. Ground truth would be relevant for a clinical study assessing efficacy, which is not described.

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

This information is not provided. Adjudication methods are typically used in clinical trials to resolve discrepancies in expert assessments, which is not applicable here.

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

This information is not provided. The device is an LED light device for acne and wrinkles, not an AI-assisted diagnostic tool for human readers.

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

This information is not provided. This question is not applicable to a physical light therapy device.

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

This information is not provided. As no clinical efficacy study is detailed, no ground truth related to clinical outcomes is discussed. The "ground truth" for the nonclinical performance data would be the defined standards themselves (e.g., passing a specific electrical safety test).

8. The sample size for the training set

This information is not provided. Training sets are relevant for machine learning algorithms, which is not what this device is.

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

This information is not provided. Not applicable for this device type.

Summary of available information regarding acceptance criteria and "study" (nonclinical data):

The "study" presented is a series of nonclinical performance tests to ensure the device meets safety and engineering standards and demonstrates substantial equivalence based on technical specifications rather than a clinical efficacy trial.

Acceptance Criteria Category	Specific Criteria (from referenced standards)	Reported Device Performance
Electrical Safety	IEC 60601-1:2005; ANSI/AAMI ES60601-1: 2005 + CORR. 1 (2009) + A2 (2010); CAN/CSA C22.2 No.60601-1-08 incorporates Corrigendum 2; June 2011: General requirements for basic safety and essential performance of medical electrical equipment.	Tested and found in compliance.
Electromagnetic Compatibility (EMC)	EMC 60601-1-2:2014 Medical Electrical Equipment- Part 1-2: General Requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests.	Tested and found in conformity.
Specific Light Source Safety	IEC 60601-2-57, Medical electrical equipment-Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.	Tested and found in compliance.
Biocompatibility (In Vitro Cytotoxicity)	ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity, 1999.	Tested and found in compliance.
Biocompatibility (Irritation & Hypersensitivity)	ISO 10993-10. Biological Evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity, 1996.	Tested and found in compliance.
Substantial Equivalence (Primary "Criteria")	The device's technical specifications and intended use are similar enough to predicate devices such that it raises no new questions of safety and effectiveness. This includes matching wavelengths (410nm and 650nm), similar treatment duration, and similar treatment regimen to the predicate devices (Nutra Light Blue K132838 and Nutra Light Red K141308). The only difference (interchangeable heads) must not raise new safety/effectiveness concerns.	Wavelengths: 410nm (blue light) and 650nm (red light) - Matches predicates. Treatment Duration: Same as predicates. Treatment Regimen: Similar to predicates. Interchangeable Heads: This feature was deemed not to raise new issues of safety and effectiveness. Conclusion: Substantially equivalent to predicate devices.

In essence, the "acceptance criteria" for K150370 were primarily met by demonstrating compliance with recognized safety and performance standards for medical electrical equipment and establishing substantial equivalence to previously approved devices based on similar technology and intended use, rather than a de novo clinical efficacy study with defined clinical endpoints.

Summary

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

Nutra Luxe MD, LLC Ms. Gloria Avendano Regulatory Affairs Manager 6835 International Center Boulevard Unit 4-5 Fort Myers, Florida 33912

July 22, 2015

Re: K150370 Trade/Device Name: Nutra Light Advanced 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. OHS Dated: May 14, 2015 Received: June 22, 2015

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. Isting 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

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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/Resourcesfor You/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joshua C. Nipper -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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K150370 Indications for Use

510(k) Number (if known): pending

Device Name: Nutra Light Advanced

Indications for Use:

Nutra Light Advanced is intended/indicated for over the counter use for the treatment of mild to moderate acne and for the treatment of periorbital wrinkles and rythides.

Prescription Use (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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FDA 510(k) Summary of Safety and Effectiveness for Nutra Light Advanced

1. General Information

Submitter: NutraLuxe MD, LLC 6835 International Center Blvd., Unit 4-5 Fort Myers, Florida 33912

Contact Person: Gloria Avendano Regulatory Affairs Manager NutraLuxe MD 6835 International Center Blvd., Unit 4-5 Fort Myers, FL 33912 Gloria@nutraluxemd.com 239-561-9699

Summary Preparation Date: 02-05-2015

2. Device

Device Name:	Nutra Light Advanced
Classification Name:	Laser Surgical Instrument, for use in General andPlastic Surgery and in Dermatology
Regulation Numbers:	21 CFR 878.4810
Regulatory Class:	II
Product Codes:	OLP and OHS
Common name:	LED Light device

3. Predicate Device:

Nutra Light Advanced is substantially equivalent to the following predicate devices;

DEVICE	510(k)	MANUFACTURER
1. Nutra Light Blue	K132838	NutraLuxe MD, LLC
2. Nutra Light Red	K141308	NutraLuxe MD, LLC

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4. Device Description

5. Intended Use and Indications:

Nutra Light Advanced is intended/indicated for over the counter use for the treatment of mild to moderate inflammatory acne and for the treatment of periorbital wrinkles and rhytides.

6. Substantial Equivalency & Comparison of Technological Similarities and Differences

NutraLuxe MD wishes to use the following devices as predicates;

Device	510(k)	Manufacturer
Nutra Light Red	K141308	Nutra Luxe MD
Nutra Light Blue	K132838	Nutra Luxe MD

Nutra Light Advanced has the same intended use as predicate devices: Nutra Light Red and Nutra Light Blue for the treatment of mild to moderate inflammatory acne and treatment of periorbital wrinkles and rhytides.
. Nutra Light advanced has 410nm wavelength and 650nm wavelength as the predicate devices have a 410nm wavelength and 650nm wavelength.
Nutra Light Advanced utilizes the same treatment duration as predicate devices.
Nutra Light Advanced utilizes similar treatment regimen as predicate devices. ●

The only difference between the Nutra Light Advanced and its predicates is the interchangeable heads feature. This feature raises no new issues of safety and effectiveness. Thus, Nutra Light Advanced is substantially equivalent.

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7. Nonclinical Performance Data:

Nutra Light Advanced has been tested and found in compliance with performance standards that have been established for such devices under section 878 of the Federal Food, Drug and Cosmetics Act. The device has been tested and is in conformity with the following requirements:
. IEC 60601-1:2005; ANSI/AAMI ES60601-1: 2005 + CORR. 1 (2009) + A2 (2010); CAN/CSA C22.2 No.60601-1-08 incorporates Corrigendum 2; June 2011.
EMC 60601-1-2:2014 Medical Electrical Equipment- Part 1-2: General Requirements . for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests.
IEC 60601-2-57, Medical electrical equipment-Part 2-57: Particular requirements for . the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for in vitro ● cytotoxicity, 1999.
ISO 10993-10. Biological Evaluation of medical devices-Part 10: Tests for irritation ● and delayed-type hypersensitivity, 1996.

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8. Regulatory Requirements

NutraLuxe MD manufactures under strict quality assurance guidelines and US FDA Good Manufacturing Practice (GMP). NutraLuxe MD is fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations (QSR), Risk Analysis and Risk Management files (RMF) conforms to ISO 14971.

Conclusion:

Based upon the indications for use and data provided in this pre-market notification, all functional modes of the Nutra Light Advanced have been shown to be substantially equivalent to current marketed predicate devices. Nutra Light Advanced emits red and blue light at the same wavelength as the predicate devices. NutraLuxe MD believes that no significant differences exist between the device and the predicates listed in section 6. Therefore Substantial equivalency is requested. The minor differences between Nutra Light Advanced and the predicate devices raise no new issues of safety and effectiveness as its predicates. Thus, Nutra Light Advanced is substantially equivalent.

Regulation Number and Section

§ 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.