Pulsaderm Acne Device
FDA 510(k) K161941 · Nutra Luxe MD, LLC
510(k) numberK161941
Submission
- Device name
- Pulsaderm Acne Device
- Applicant
- Nutra Luxe MD, LLC
Fort Myers, FL, US - Received
- July 15, 2016
- Decision date
- October 19, 2016
- 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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More from Li-Tek Electronics Technology C0., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K162371 | Pulsaderm ACE-All BlueOLP · Traditional | 12/15/2016SE |
| 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 |
| K132838 | Nutra Light BlueOLP · Traditional | 05/23/2014SE |
Questions and answers
When was Pulsaderm Acne Device cleared by the FDA?
Pulsaderm Acne Device (K161941) received a 510(k) decision of Substantially Equivalent on October 19, 2016, 96 days after the submission was received.
What is the product code of K161941?
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.