Pulsaderm Acne Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K161941 ↗

FDA Product Code

OLP

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What types of acne severity can the Pulsaderm Acne Device treat, and how does it work?

  The Pulsaderm Acne Device is designed to target and treat mild to moderate acne by delivering controlled light-based energy to affected skin areas. It works through a technology that promotes reduction of acne lesions and inflammation, helping to improve skin condition for patients within this severity range. The device is not intended for severe acne or other dermatological conditions.

• Is the Pulsaderm Acne Device available for both clinical and home use, and how is it supplied?

  Yes, the Pulsaderm Acne Device is intended for use in both clinical and home settings. It is supplied as either a single-use or reusable system, depending on the specific model and accessories included. This flexibility allows clinicians to integrate it into professional treatments while also enabling patients to use it at home for continued care.

• Can the Pulsaderm Acne Device be used in an MRI environment, and what safety precautions should be followed?

  No, the Pulsaderm Acne Device is not MRI-safe. If used in a facility with MRI machines, it must be removed from the patient and stored away from the MRI area to prevent interference or damage. Always follow the manufacturer’s instructions for proper handling, storage, and maintenance to ensure safe and effective use.

• What regulatory pathway was followed for FDA clearance of the Pulsaderm Acne Device, and what does this mean for its use?

  The Pulsaderm Acne Device was cleared through the FDA 510(k) pathway, specifically under the classification 21 CFR 878.4810 for Over-the-Counter Powered Light-Based Lasers for Acne. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the U.S. as a Class II medical device. The clearance does not imply it is approved for any specific clinical indication beyond its intended use for mild to moderate acne.

• Are there multiple models or variations of the Pulsaderm Acne Device, and how can I identify the correct one for my needs?

  Yes, the Pulsaderm Acne Device comes in multiple models and accessory configurations, as indicated by the extensive list of registration numbers (e.g., 3015646995, 3019015047, etc.). These variations likely correspond to different single-use or reusable systems, potentially with differing features like handpiece types or energy settings. To identify the correct model, refer to the manufacturer’s documentation or contact Nutra Luxe MD, LLC for guidance tailored to your clinical or home-use requirements.