(159 days)
Not Found
No
The device description and performance studies focus on light emission and electrical safety standards, with no mention of AI or ML capabilities.
Yes
The device is intended/indicated for the treatment of mild to moderate acne and periorbital wrinkles and rhytides, which are therapeutic applications. It also references "therapeutic" use in the performance studies section.
No
The device is intended for treatment of acne and wrinkles, not for diagnosis. While one of the performance standards mentions "therapeutic, diagnostic, monitoring and cosmetic/aesthetic use," the specific "intended use" and "device description" do not indicate a diagnostic function.
No
The device description clearly states it is a physical device made of Lustran ABS with clear cover lenses, LED light sources, exchangeable heads, and a hand-held control unit. It is a hardware device that emits light and/or heat.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Nutra Light Advanced Function: The description clearly states that the Nutra Light Advanced is a visible light and/or heat source intended for the treatment of acne and wrinkles. It applies light directly to the skin.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient.
The device is a therapeutic device that uses light energy applied externally to the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OLP, OHS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Periorbital
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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
1
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 and |
| Plastic 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
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.
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.