Nutra Light Blue
FDA 510(k) K132838 · Nutra Luxe MD, LLC
510(k) numberK132838
Submission
- Device name
- Nutra Light Blue
- Applicant
- Nutra Luxe MD, LLC
Sparks, NV, US - Received
- September 10, 2013
- Decision date
- May 23, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLP – Over-The-Counter Powered Light Based Laser For Acne
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.
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| K220729 | The Luminance RED Acne DeviceOLP · Traditional | Luminance Medical Ventures, Inc. | 06/09/2022SE |
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More from Li-Tek Electronics Technology C0., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K162371 | Pulsaderm ACE-All BlueOLP · Traditional | 12/15/2016SE |
| K161941 | Pulsaderm Acne DeviceOLP · Traditional | 10/19/2016SE |
| K160728 | NutraStim Hair Laser HelmetOAP · Traditional | 09/16/2016SE |
| K150826 | Nutra Face Lift Model PE8050NFO · Traditional | 02/10/2016SE |
| K150370 | Nutra Light AdvancedOLP · Traditional | 07/22/2015SE |
| K141596 | Nutra Stim Hair Laser CombOAP · Traditional | 01/08/2015SE |
| K141588 | Nutra Stim Hair Laser CombOAP · Traditional | 01/08/2015SE |
| K141308 | Nutra Light RedOHS · Traditional | 08/20/2014SE |
Questions and answers
When was Nutra Light Blue cleared by the FDA?
Nutra Light Blue (K132838) received a 510(k) decision of Substantially Equivalent on May 23, 2014, 255 days after the submission was received.
What is the product code of K132838?
The FDA product code is OLP – Over-The-Counter Powered Light Based Laser For Acne, a Class II (moderate risk) device regulated under 21 CFR 878.4810.